FDA Sent These 6 Warning Letters for Food Companies | July 2018

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FDA Sent These 6 Warning Letters for Food Companies | July 2018

By | 2018-08-24T08:20:04+00:00 August 15th, 2018|CGMP, FDA Inspections, FDA Warning Letters, Food, FSMA|

We took a snapshot of the 6 warning letters the FDA sent to food companies last month. Food violations ranged from failing to implement sanitation preventive controls to failing to have an HACCP plan.

From companies in Texas, Puerto Rico, and more, here they are:

  • Roorda Dairy, LLC, Paullina, IA – violations include but are not limited to:
    • Failed to use appropriate supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a) and resulted in illegal drug residues, in violation of 21 C.F.R. § 530.11(d).
    • Failed to follow the FDA’s established tolerance of 12 ppm for residues of tetracycline in the kidney tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), section 556.500(b)(3) (21 C.F.R. § 556.500(b)(3)).

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  • Aegle Nutrition, LLC, Carrollton, TX – violations include but are not limited to:
    • Failed to establish the following specifications for each component that were used in the manufacture of a dietary supplement:
      • Component specifications that are necessary to ensure that specifications for the identity purity, strength, and composition of dietary supplements manufactured using the components are met (21 CFR 111.70(b)(2));
      • Limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of dietary supplement to ensure the quality of the dietary supplement (21 CFR 111.70(b)(3)).
    • Quality control personnel approved and released for distribution a batch of dietary supplement that did not meet established product specifications, in violation of 21 CFR 111.123(b)(2).
    • MMRs did not identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, and that the dietary supplement is packaged and labeled as specified in MMR, as required by 21 CFR 111.205(b)(1).
    • Failed to – as a commercial processor in the thermal processing of acidified foods – (no later than 60 days after registration and prior to the packing of a new product) provide the FDA information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative level, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2).
    • Failed to fully reprocess, thermally process as a low-acid canned food under 21 CFR 113, or set aside for further evaluation as to any potential public health significance, a portion of food which deviated from a scheduled process, as required by 21 CFR 114.89.
    • Failed to thermally process acidified foods to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance and those of nonhealthy significance capable of growing in the food, as required by 21 CFR 114.80(a)(1).
  • Kerry, Inc., Beloit, WI – violations include but are not limited to:
    • Hazard analysis did not identify a known or reasonably foreseeable hazard for each type of food manufactured, processed, packed, or held at facility to determine whether there are any hazards requiring a preventive control as required by 21 CFR 117.130(a)(1).
    • Failed to 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 facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 U.S.C. §§ 342 or 343(w)) to comply with 21 CFR § 117.135(a)(1).
    • Did not implement written corrective action procedures that must be taken if preventive controls are not properly implemented to comply with 21 CFR 117.150(a)(1) and (d).
    • Did not verify that sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing a hazard with environmental monitoring as required by 21 CFR 117.165(a).
  • Lopez Gonzalez Santana Corporation (dba Domel and dba Dermixx), Rio Piedras, Puerto Rico – violations include but are not limited to:
    • Failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103.
    • Failed to establish and follow written procedures for how to review and investigate product complaints, as required by 21 CFR 111.553.
    • Failed to establish and follow written procedures to fulfill the requirements for returned dietary supplements, as required by 21 CFR 111.503.
    • Did not collect and hold reserve samples of each lot of packaged and labeled dietary supplement that is distributed, as required by 21 CFR 111.83(a).
  • GC Natural, Buena Park, CA – violations include but are not limited to:
    • Failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103.
    • Failed to establish specifications for dietary supplement labels (label specifications), as required by 21 CFR 111.70(d).
    • Failed to establish and follow written procedures for holding operations, as required by 21 CFR 111.453.
    • Failed to establish and follow written procedures to fulfill the requirements for returned dietary supplements as required by 21 CFR 111.503.
    • Failed to establish and follow written procedures to fulfill the requirements that apply to product complaints, as required by 21 CFR 111.553.
  • SIA Piejura, Latvia – violations include but are not limited to:
    • Failed to have an HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3).
    • Failed to have an HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4).

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About the Author

Patty Harvey

Patty Harvey, a nationally recognized food expert and speaker, is the Food Product Manager at FDAzilla. Patty joins FDAzilla from PL Harvey Consulting, LLC where she continues to consult for the world’s top food companies.

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