Warning letters sent to two seafood processing facilities and cheese manufacturing facility - Food Safety News

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent.

Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Ee Hui Food Manufacture PTE Ltd. — Singapore
The Food and Drug Administration sent a warning letter dated Nov. 22, 2019, to the president of Ee Hui Food Manufacture PTE Ltd., Cheng Hwee Ng.

During an inspection at Ee Hui Food Manufacture’s seafood processing facility on June 24 and 25, FDA investigators found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). The warning letter says that, “failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4).”

In response to these deviations, the FDA issued an FDA 483 Inspectional Observations form that lists deviations observed at the facility.

The violations noted by the FDA:

1. “You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.G(a) and (c)(l). A food safety hazard is defined in 21 CFR 123.3{f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s revised HACCP plan entitled “Cooking & Frying Products” does not list the food safety hazards of Clostridium botulinum (C. botulinum) growth and toxin formation and undeclared allergens. C. botulinum growth and toxin formation is reasonably likely to occur in your vacuum packaged products as this packing type creates an anaerobic condition conducive to growth and toxin formation when mishandled, particularly when products are refrigerated (i.e., not frozen). Specifically, this hazard is reasonably likely during thawing of your vacuum packaged surimi, during chilled storage of your refrigerated vacuum packaged finished products, and throughout distribution of your refrigerated vacuum packaged finished product. The hazard of undeclared allergens is reasonably likely to occur because your firm manufactures products that contain fish (threadfin bream), crustacean shellfish {shrimp), wheat, egg, dairy, and soy.”
2. “You must have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(c)(2). A critical control point is defined in 21 CFR 123.3(b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.” However, your firm’s revised HACCP plan entitled “Cooking & Frying Products,” does not list one or more critical control points for cooling after cooking and frying to control the food safety hazard of pathogenic bacteria growth and toxin formation, as a result of post processing contamination.”
3. “You must have a HACCP plan that at a minimum lists the critical limits that must be met, to comply with 21 CFR 123.6{c)(3). A critical limit is defined in 21 CFR 123.3{c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, your firm’s revised HACCP plan entitled “Cooking & Frying Products”;”
4. “Lists a critical limit of “(redacted)” at the “(redacted)” and “(redacted)” critical control point that is not adequate to control pathogenic bacteria survival through cooking because you do not have critical limit values for cook times and temperatures as part of your HACCP plan. Specifically, you could not provide a temperature chart for the “(redacted)” and “(redacted)” critical control point, as referenced in your plan, to indicate time and temperature parameters adequate to control pathogenic bacteria survival through cooking were achieved. We acknowledge receipt of what appear to be monitoring records such as the “(redacted)” (i.e., your ” (redacted)” ) and the “(redacted)” (i.e., the “ (redacted)” critical control point monitoring record). We also note the products listed for each do not appear to be the same products listed. Once you establish adequate critical limits at the “(redacted)” and “(redacted)” Critical control points, FDA recommends that you monitor the temperature of the cooker and fryer using a continuous temperature recording device (for example, a recording thermometer) with continuous monitoring by the device itself and a visual check of the recorded data at least once per day. FDA also recommends that you monitor the speed of the belt using a stopwatch or tachometer to monitor the speed of the belt drive wheel at least once per day, and whenever any changes in belt speed are made.”
5. “Lists a critical limit of “(redacted)” at the “(redacted)” critical control point that is not adequate to control pathogenic bacteria growth and toxin formation. Specifically, the critical limit does not list a value for the temperature of the chiller. Once your firm establishes an appropriate critical limit at the “(redacted)” critical control point, FDA recommends that you monitor the ambient air temperature of the cooler using a continuous temperature-recording device (for example, a recording thermometer) with continuous monitoring by the device itself and a visual check of the recorded data at least once per day.”
6. “Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123. 7(b). However, your corrective action plan for frozen, vacuum packed, surimi-based products at the “(redacted)” and “(redacted)” critical control points to control pathogenic bacteria growth is not appropriate. In addition, to correcting the cause of the deviation, your corrective action must ensure that no adulterated product enters commerce.”

A complete list of the violations can be found in the FDA’s warning letter.

U.S. Dairy Unlimited LLC — Miami, FL
The Food and Drug Administration sent a warning letter dated Nov. 19, 2019, to Ury Zyman, owner of U.S. Dairy Unlimited LLC.

During an inspection at U.S. Dairy Unlimited LLC, a ready-to-eat (RTE) cheese manufacturing facility, from June 24 to July 3, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). The warning letter says that, “based on FDA’s inspectional findings, we determined that cheese products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)).”

In response to these deviations, the FDA issued an FDA 483 Inspectional Observations form that lists deviations observed at the facility.

The violations noted by the FDA:

Hazard Analysis and Risk-Based Preventive Controls (Subpart C):

1. “You did not conduct a hazard analysis for any of your products. Specifically, you did not identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required by 21 CFR § 117.130(a).”
2. “You did not identify the biological hazards of pathogen survival of a lethal treatment and pathogen growth due to a lack of time/temperature control during the manufacture of your cheese products and storage of finished cheese products as known or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control. During the inspection we observed that you were not following your time and temperature pasteurization parameters of (redacted) degrees Fahrenheit for (redacted) minutes. Additionally, we did not observe firm employees monitoring the temperature of the product post-pasteurization and of coolers for finished product storage.”
3. “You did not evaluate environmental pathogens, such as Listeria monocytogenes and Salmonella, to determine whether environmental pathogens are a hazard requiring a preventive control to comply with 21 CFR § 117.130(c)(1)(ii). Specifically, your facility manufactures RTE food which is exposed to the environment prior to packaging. After your products undergo a lethal treatment (pasteurization), they are exposed to the environment before being packaged. The packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen.”
4. “You did not identify the physical hazard of metal as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control. While your firm was in operation during our inspection, we observed the use of utility knifes to open powdered ingredients prior to pasteurization, metal wires used in cutting the RTE cheese, and metal staples for sealing the packaged boxes of RTE cheese.”
5. “You did not identify undeclared allergens due to incorrect labeling as a known or reasonably foreseeable hazard to determine whether the hazard requires a preventive control. Your facility manufactures cheese products in which milk and milk-containing products are used as ingredients.”
6. “You did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under Section 402 of the Act or misbranded under section 403(w) of the Act [21 CFR § 117.135(a)(1)]. Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR § 117.135). Preventive controls are subject to preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system (see 21 CFR § 117.140).”
7. “You did not prepare or have prepared and did not implement a written food safety plan for any of the products manufactured in your facility, as required by 21 CFR § 117.126(a)(1). A food safety plan must include the following:”
8. “The written hazard analysis, as required by § 117.130(a)(2);”
9. “The written preventive controls, as required by § 117.135(b);”
10. “The written supply-chain program, as required by subpart G;”
11. “The written recall plan, as required by § 117.139(a);”
12. “The written procedures for monitoring the implementation of the preventive controls, as required by § 117.145(a);”
13. “The written corrective action procedures, as required by § 117.150(a)(1);”
14. “The written verification procedures, as required by § 117.165(b).”

Current Good Manufacturing Practice (Subpart B):

1. “Your plant was not constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials, as required by 21 CFR § 117.20(b)(4).”
2. “Condensate dripping onto the inverting perforated stainless steel vessels containing molds packed with RTE soft white cheese.”
3. “Condensate dripping onto stainless steel molds containing RTE cheese and sanitized flexible blue mold liners used inside round molds for RTE cheese.”
4. “Condensate dripping from the cooling system onto acrylic sheets located above the racks and then onto the molds and vessels containing the RTE cheese.”
5. “Condensate dripping from the ceiling onto the inverting vessels storing the RTE cheese.”
6. “You did not maintain your plant in a clean and sanitary condition and in repair adequate to keep food from becoming adulterated, as required by 21 CFR § 117.35(a). Specifically, we observed:”
7. “During the removal of RTE soft white cheese from the stainless-steel molds, a firm employee was observed banging the molds against the handle of a metal platform cart in order to loosen the RTE soft white cheese from its mold. During this process, the RTE soft white cheese came in direct contact with the handle of the metal platform cart. The metal handles were observed to have indentations with non-smooth cleanable surfaces. The (redacted) pipe which transports the pasteurized liquid cheese product into the mixing tank was corroded and filthy with what appeared to be food debris accumulated over time and was leaking liquid cheese product freely onto the floor.”
8. “The pipes under the hand wash stations in the Packing Room and Production Area were leaking waste water directly onto the floor.”
9. “The (redacted) sink in the Packing Room was not used properly for washing utensils and equipment. A (redacted) ladder was placed into the third compartment after being used during packing. No detergent or sanitizer was observed at the (redacted) sink.”
10. “You did not clean your non-food contact surfaces in a manner and as frequently as necessary to protect against contamination of food, food-contact surfaces, and food-packaging materials, as required by 21 CFR § 117.35(e). Specifically, we observed your employees using a (redacted) hose to spray water onto the manufacturing room floor and into a floor drain to remove food debris. Water from the floor was splashing all around and directly on the vessels containing RTE soft white cheese product.”

A complete list of the violations can be found in the FDA’s warning letter.

Delfino Battista SRL — Montecorvino Pugliano, Italy
The Food and Drug Administration sent a warning letter dated July 02, 2019, to Amedeo Giuseppe Battista, owner and CEO of Delfino Battista SRL.

During an inspection at Delfino Battista SRL’s seafood processing facility from Feb. 22-25 FDA investigators found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). The warning letter says that, “in accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your anchovy products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.”

In response to these deviations, the FDA issued an FDA 483 Inspectional Observations form that lists deviations observed at the facility.

The violations noted by the FDA:

1. “You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.” However, your firm’s revised HACCP plans, dated March 1, 2019, provided with your response for your anchovy products entitled “Anchovies in Oil Production”, “Production Anchovies Salted From fresh product” and “Production Anchovies Salted From Semiprocessed” do not list critical control points for in-process refrigerated storage (i.e., storage period occurring while products are in-process), to control pathogen growth and toxin formation including Clostridium botulinum (C. botulinum) in your uneviscerated fish. After receiving fresh uneviscerated fish and fish which are salted and eviscerated, (redacted); however, you do not have this listed in your plan as critical control points with appropriate monitoring procedures, recordkeeping, etc. Pathogen growth and toxin formation, including C. botulinum in your uneviscerated fish, is reasonably likely to occur if the fish is stored under inadequate temperatures.”

“Therefore, FDA recommends this refrigerated storage step be listed as a critical control point with a critical temperature limit of below 38°F (3.3°C) refrigeration temperature to control non-proteolytic C. botufinum in the uneviscerated fish. To control pathogen growth and toxin formation in the salted, eviscerated fish, FDA recommends a critical temperature limit of below 40°F (4.4°C). Furthermore, the refrigeration temperature should be measured using a continuous temperature-recording device, with a visual check of the recorded data at least once per day.”

“In addition, we note that our investigator observed the refrigeration unit that was storing raw uneviscerated fish and semi-finished anchovies at (redacted)°C ((redacted)°F), which is above FDA’s recommendation of below 38°F (3.3°C) for uneviscerated fish and below 40°F (4.4°C) for salted, eviscerated fish. Furthermore, review of temperature monitoring records revealed several temperatures found to be above ((redacted)°C ((redacted)°F) and as high as (redacted)°C ((redacted)°F) in 2018.”

2. “You must have a HACCP plan that, at a minimum, lists the critical limits that must be met to comply with 21 CFR 123.6 (c)(3). A critical limit is defined in 21 CFR 123.3 (c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, your firm’s revised HACCP plans, dated March 1, 2019, provided with your response for your anchovy products entitled “Anchovies in Oil Production”, “Production Anchovies Salted From fresh product” and “Production Anchovies Salted From Semiprocessed” list critical limits that are inadequate to control the identified food safety hazards.”
3. “The receiving critical control points in all three of your HACCP plans for your anchovy products list a critical limit of “(redacted).” This critical limit is inadequate to control scombrotoxin (histamine) formation and pathogen growth and toxin formation. FDA recommends a critical limit that lists fish are to be completely surrounded by ice during transit and at the time of delivery.”
4. “The “(redacted)” critical control points in all three of your HACCP plans for your anchovy products identify the hazard “(redacted)” but does not include a critical limit to control undeclared allergens. FDA recommends that the critical limit lists all major food allergens in the product formulation on all finished product labeling.”
5. “For the “Production Anchovies Salted From Fresh Product” HACCP plan, your receiving critical control point lists critical limits that are not adequate to control the hazard of histamine formation when receiving fresh uneviscerated anchovies. FDA recommends sensory examination, taking internal temperatures, and controls for either harvest vessel records or histamine testing with a limit of less than 50 ppm histamine as critical limits.”
6. “For the “Production Anchovies Salted From Fresh Product” HACCP plan, you do not list controls for the hazard of preformed botulinum toxin in fresh uneviscerated anchovies. FDA recommends a critical limit that requires the uneviscerated fish be five inches or less (from head to tail) and that the fish be boiled for at least 10 minutes to denature preformed C. botulinum toxin before processing (e.g ., evisceration, brining, etc.). You may choose to control preformed botulinum toxin at the receiving critical control point or as a separate critical control point.”
7. “For the “Production Anchovies Salted From Fresh Product” HACCP plan, the “(redacted)” critical control point lists a critical limit of “(redacted)%” for “(redacted)“. This is not adequate to control C. botulinum growth and toxin formation during maturation at ambient temperatures of (redacted)C ((redacted)°F) for (redacted) months. FDA recommends that the critical limits list the critical factors for brining/maturation as established by a scientific study that are necessary to ensure that the finished product has a water phase salt level of 20% or higher that is achieved within 2 hours. As an alternative to measuring the critical factors, the water phase salt level of the finished product for each batch can be analyzed and recorded. Additionally, if anchovies are received already salted to a water phase salt level of 20% or higher by a previous processor, then the water phase salt level should be verified by documentation from the previous processor or by testing upon receipt. Furthermore, if these products are further processed in a manner that could reduce the salt levels (e.g., removal of brine, washing in water, filleting and packing in oil), then finished product testing should also be done.”
8. “Because you chose to include a corrective action plan in your HACCP plan, your described corrective action must be appropriate, to comply with 21 CFR 123.7(b). However, your listed corrective actions for your anchovy products are not appropriate because they do not ensure that adulterated product does not enter commerce. When processors include corrective actions in their HACCP plan, the corrective actions must ensure that no adulterated product enters commerce as a result of a deviation and the cause of the deviation is corrected.”

A complete list of the violations can be found on the FDA’s warning letter page.

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