Warning Letters sent to D.A.Y Farm and PT.  SIG ASIA

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.

D.A.Y. Farm — Saint Charles, MN

The Food and Drug Administration sent a warning letter dated Nov. 20, 2019, to the owner of D.A.Y. Farm, Daniel Yoder.

During an inspection at D.A.Y. Farm’s shell egg farm in Saint Charles, MN, on July 15, 16, and 18, 2019, FDA investigators found serious violations of the Prevention of Salmonella Enteritidis. The warning letter says that “Failure to comply with the provisions of 21 CFR 118 causes your shell eggs to be in violation of section 361(a) of the Public Health Service Act (the PHS Act), 42 U.S.C. § 264(a).  In addition, these violations render your shell eggs 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 have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.”

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

The FDA says they received a written response postmarked July 30, 2019, concerning their investigators’ observations noted on the Form FDA-483 (FDA-483)

The violations noted by the FDA:

1. “Your firm failed to have and implement a written Salmonella Enteritidis prevention plan (SE Plan) that includes, at minimum, the SE prevention measures, as required by 21 CFR 118.4.  Specifically, your plan fails to include the following required SE prevention measures:”
2.  “Procurement of pullets that are SE-monitored or raised under SE-monitored conditions;”
3.  “Biosecurity program;”
4.  “Rodents, flies, & other pest control;”
5.  “Procedures for cleaning & disinfecting the poultry house;”
6.  ‘Holding and transporting eggs at or below 45 degrees Fahrenheit beginning 36 hours after the time of lay.”

  “Your written response does not include a written plan that addresses the procurement of pullets, a biosecurity program, and procedures for cleaning and disinfecting the poultry house.   Regarding pest control, your response provides an overview of your programs. It does not include information on how you will monitor by visual inspection of rodents, in addition to the mechanical monitoring method, as required by 21 CFR 118.4(c).” 

  “Regarding refrigeration, your response states that you plan to change the threshold “very soon” for refrigeration of shell eggs and that your cooler temperature needs to be (redacted) degrees.  You further state that if the temperature exceeds (redacted) degrees for (redacted) hours and your unit is not fixed, you will “(redacted).”  Your response is inadequate, as you must hold and transport eggs at or below 45 degrees Fahrenheit beginning 36 hours after the time of lay, as required by 21 CFR 118.4(e).  Furthermore, during the inspection, you indicated that you do not check cooler temperatures during the (redacted).  You must maintain continuous refrigeration of shell eggs 36 hours after the time of lay and maintain records documenting refrigeration, as required by 21 CFR 118.10(a)(3)(iv).  We also note that you documented a temperature range of (redacted) degrees Fahrenheit rather than an exact temperature on your refrigeration records.  You must record the actual values observed, as required by 21 CFR 118.10(b)(4).”

  “We will verify the adequacy of your pest control program and documentation of compliance with refrigeration requirements of your shell eggs during the next inspection of your farm.”

2. “Your firm failed to conduct environmental testing for SE in your poultry house when laying hens were 40 to 45 weeks of age, as required by 21 CFR 118.5(a).  Your environmental testing record dated November 25, 2016, for the flock (redacted) shows that the flock was tested at (redacted) weeks of age.  In addition, you were unable to provide documentation showing that environmental testing for SE was conducted on subsequent flocks (flock (redacted) and flock (redacted)) when laying hens were 40-45 weeks of age (redacted) and (redacted) respectively).”  

  “Your response states that going forward you intend to mark your calendar at (redacted) weeks of age.  We will evaluate the sufficiency of your testing and documentation during the next inspection.” 

3. “You do not have documentation that you procured pullets that were SE-monitored or were raised under SE-monitored conditions, including environmental testing records for pullets, as required by 118.4(a)(2), to comply with 21 CFR 118.10(a)(2).  Specifically, you could not provide any documentation to show your flock (redacted) pullet environment was tested for SE when they were 14 to 16 weeks of age.”

“Your response states that you will let your pullet grower “know” and make sure testing is done at (redacted) weeks.  It is your responsibility, as a producer, to verify that the pullet environment is tested at 14-16 weeks of age.  When developing your SE plan, you should include verification that you are receiving pullets raised under SE-monitored conditions, including testing at required timeframes.  We will evaluate the sufficiency of the testing and your documentation during the next inspection.” 

“The above violations are not meant to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your shell egg production facility operates in compliance with all applicable statutes and regulations, including the Act, the PHS Act, and the Shell Egg regulation.  You are also responsible for using procedures to prevent future violations of these statutes and regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures under 21 CFR 118.12(a).  If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.”

“We reviewed your most recent environmental testing record which is dated November 25, 2016, and it indicates that you obtained (redacted) swabs from your (redacted) house.  (redacted) swabs is not a sufficient number of swabs to be representative of the environment.  The FDA recommends the collection of at least ten swabs, which is dependent on your (redacted) poultry house size, to obtain a representative sample in the environment.  Please refer to FDA’s December 2011, Guidance for Industry on “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation,” www.fda.gov/media/82653/download, for additional information.”

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

PT.  SIG ASIA — Bitung, Indonesia

The Food and Drug Administration sent a warning letter dated Oct. 28, 2019, to the chairwoman of PT. SIG ASIA, Shaun Tan.

The United States Food and Drug Administration (FDA) on July 12, 2019, requested a copy of PT. SIG ASIA’s HACCP plan for the scombrotoxin-forming fish they import into the United States. PT. SIG ASIA provided a HACCP plan entitled “HACCP FROZEN TUNA” for their tuna products, which are intended to be consumed raw or cooked, shipped frozen, and maybe vacuum packaged, as well as 5 complete sets of monitoring records associated with the HACCP plan.  The FDA’s review of the HACCP plan and records revealed that the plan demonstrated serious deviations from the requirements of the seafood Hazard Analysis Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123).

In response to these deviations, the FDA 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 tuna products are adulterated, in that, they have been prepared, packed or held under conditions whereby they may have been rendered injurious to health.”

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 123.6 (a) and (c)(1).  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 HACCP plan entitled “HACCP FROZEN TUNA” dated April 14, 2019, does not list the food safety hazard of pathogen growth and toxin formation as a result of time and temperature abuse that is reasonably likely to occur in your raw ready-to-eat products.”

“According to your HACCP plan, your firm (redacted). Pathogen growth is reasonably likely to occur in fish and fishery products that are exposed to unrefrigerated temperatures (e.g. temperatures above 4.4° C (40° F) for unsafe periods of time.  Therefore, FDA recommends your HACCP plan include controls for pathogens in your ready-to-eat tuna products.”

2. “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 HACCP plan entitled “HACCP FROZEN TUNA” does not list a critical control point for unrefrigerated processing, or critical control points for all of the unrefrigerated processing steps, for controlling the food safety hazard of scombrotoxin (histamine) formation. Your HACCP plan should include a control for unrefrigerated processing from when the first fish in a marked batch is removed from the ice at the “(redacted)” critical control point until the last finished product from the marked batch is placed in the freezer.”
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 HACCP plan entitled “HACCP FROZEN TUNA” lists critical limits at the following critical control points that are not adequate to control scombrotoxin (histamine) formation and Clostridium botulinum toxin formation:”

• “At the “(redacted)” critical control point, to control scombrotoxin (histamine) formation, FDA recommends that, in addition to your critical limits for histamine testing and internal temperature, your HACCP plan lists a critical limit for sensory analysis of a representative number of fish that shows decomposition in less than 2.5% of the fish in the sample.”
• “At the “(redacted)” critical control point, to control scombrotoxin (histamine) formation, FDA recommends the products are held at a cooler temperature of 40°F (4.4°C) or below, or the products are completely and continuously surrounded by ice throughout the storage time.”
• “At the “(redacted)” critical control point, to control Clostridium botulinum toxin formation, FDA recommends the products are held at a cooler temperature of 38°F (3.3°C) or below, or you ensure the products are completely and continuously surrounded by ice throughout the storage time. According to your description of the “(redacted)” step, your firm places tuna products in a (redacted) bag, fills with carbon monoxide gas, ties the bags closed, and stores refrigerated for up to (redacted) days.” 

4. “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 plans for frozen tuna at the following critical control points are not appropriate.”

• “At the “(redacted)” critical control point, the listed corrective actions are not appropriate to control scombrotoxin (histamine) formation.  FDA recommends that affected lots be chilled and held until histamine analysis is performed on a minimum of 60 fish collected representatively throughout the lot, including any fish measured to have temperatures that exceeded the critical limit and any fish observed to have been exposed to inadequate cooling media (or the entire lot for lots smaller than 60 fish). Reject the lot if any fish are found with histamine greater than 50 ppm (17 ppm if the lot is composited) and you discontinue use of the supplier or carrier until evidence is obtained that the identified transportation-handling practices have been improved.  Please note that is not appropriate to retest the fish in the lot to obtain compliance with the critical limit.”
•  “At the “(redacted)” critical control point, the listed corrective action, “(redacted)” is not adequate to control scombrotoxin (histamine) formation. When the critical limit is not met, FDA recommends that you chill and hold the product until it can be evaluated based on its total time and temperature exposure, including exposures during prior processing operations, destroy the product, or divert to a non-food use and ensure that the cause of the deviation is corrected.”
• “At the “(redacted)” critical control point, the listed corrective actions, “(redacted)” are not adequate to control Clostridium botulinum toxin formation. When the critical limits are not met, FDA recommends that you chill and hold the affected product until an evaluation of the total time and temperature exposure is performed, destroy the product, or divert to a non-food use and correct the cause of the deviation.”
•  “At the “(redacted)” critical control point, the listed corrective actions, “(redacted)” and “(redacted)” are not adequate to control scombrotoxin (histamine) formation. When the critical limits are not met, the FDA recommends that you chill and hold the affected product until histamine analysis is performed on a minimum of 60 fish representatively collected from throughout the affected lot. Destroy the lot or divert it to a non-food use if any fish is found with histamine greater than or equal to 50 ppm (17 ppm if the lot is composited), destroy the product, or divert the product to a non-food use and correct the cause of the deviation.”
• “At the “(redacted)” critical control point, the listed corrective action, “(redacted) is not adequate by itself to control Clostridium botulinum toxin formation. FDA recommends that in addition to (redacted) you determine and correct the cause of improper labels.”

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

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