FDA Sent These 2 Warning Letters for Food Companies | November 2018

We took a snapshot of the 2 warning letters the FDA sent to food companies in November. Violations included adulterated beef and kratom contaminated with salmonella.


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  • Avalon Packaging, American Fork, UT – Violations were grouped into three categories: Pathogen Findings, CGMP Violations, and New Dietary Ingredient.
    • Pathogen Findings:
      • FDA collected three raw kratom samples that were to be used as part of finished dietary supplements. These samples produced several serotypes of Salmonella. According to FDA, “Whole Genome Sequencing (WGS) analysis was conducted on the Salmonella spp isolates obtained from the three-raw ingredient kratom samples and WGS isolated thirteen (13) different strains of Salmonella in the three samples.”
      • FDA acknowledged that Avalon Packaging voluntarily destroyed and recalled all kratom products post-outbreak.
    • Dietary Supplement CGMP Violations include:
      • 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 any 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 the master manufacturing record, as required by 21 CFR 111.70(a).
      • Failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch as required by 21 CFR 111.205(a).
      • Failed to include the complete information relating to the production and control of each batch in the batch production record (BPR) as required by 21 CFR 111.255(b).
      • After reviewing Avalon Packaging’s response dated April 13, 2018, FDA stated multiple times within the warning letter that the adequacy of the response could not be verified and that corrective actions would be evaluated at the next inspection.
    • New Dietary Ingredient:
      • According to FDA, “As an herb or other botanical, kratom is a dietary ingredient under section 201(ff)(1)(C) of the Act [21 U.S.C. § 321(ff)(1)(C)]. Further, as a dietary ingredient that was not marketed in the United States before October 15, 1994, Kratom (mitragyna speciosa) is a “new dietary ingredient” under section 413(d) of the Act [21 U.S.C. § 350b(d)]. Under section 413 of the Act [21 U.S.C. §350b], a dietary supplement that contains a new dietary ingredient (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) shall be deemed adulterated under section 402(f) of the Act [21 U.S.C. § 342(f)] unless it meets one of two requirements:
        1. The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or
        2. There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.”
  • Welter Farms Inc, Holy Cross, IA – USDA/FSIS analyzed the tissue of a beef steer sold as food and deemed it contaminated.
    • FDA stated that the “analysis of tissue samples collected from this animal identified the presence of sulfamethazine at 0.756 parts per million (ppm) in the liver, and 0.533 ppm in the muscle.  FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.670 (21 C.F.R. § 556.670).”
    • FDA also found that no physical or written records are kept regarding the treatment of sick or injured cattle, the sale or purchase of cattle, nor the identity of cattle, stating that the conditions are “so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.”

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About the Author

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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