FDA Sent These 4 Warning Letters for Food Companies | June 2018

We took a snapshot of the 4 warning letters the FDA sent to food companies last month. Food violations ranged from failing to label products (a lot!) to failing to train supervisors.

From companies in California, New York, and more, here they are:

  • LNZRO Pizza Empire, Inc, Syracuse, NY – 3 violations:
    • Fails to conduct hazard analysis for products that are produced to determine whether there are food safety hazards that are reasonably likely to occur, and failed to have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.6(a) and (b).
    • Fails to have appropriate corrective actions listed to ensure the cause of a deviation is corrected as required by 21 CFR 123.7(b)(2).
    • Fails to review critical control point monitoring records within one week after the records are made, to ensure compliance with 21 CFR 123.8(a)(3).

(NOTE: Want to know what enforcement actions are happening in your supply chain? Get your FREE SUPPLIER ASSESSMENT.)

  • Kaltec Food Packaging, Inc, Port Jervis, NY – 4 violations:
    • Fails to provide the Food and Drug Administration 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).
    • Fails to manufacture acidified food products in accordance with the scheduled process, as required by 21 CFR 114.80(a)(1).
    • Fails to have operators under the supervision of a person who has attended a school approved by the Commissioner for giving instruction in food-handling techniques, food protection principles, personal hygiene, plant sanitation practices, pH controls, and critical factors in acidification, and who has satisfactorily completed the prescribed course of instruction, as required by 21 CFR 108.25(f).
    • Fails to maintain production records of examination of raw materials, packaging materials, finished products, and supplier’s guarantees or certificates to verify compliance with FDA regulations and guidelines or actions levels as required by 21 CFR 114.100(a).
  • Health Management Group Inc, Akron, OH – 5 violations:
    • Fails 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.
    • Fails to have labeling for each product to include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
    • Fails to have product labels to include a serving size in accordance with 21 CFR 101.36(b).
    • Fails to have labels declare the place of business, including the ZIP code, in accordance with 21 CFR 101.5.
    • Fails to have labels make a declarative statement for the lack of evaluation of the product by FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease in accordance with 21 CFR 101.93(c)(1).
  • KPC Products Inc, Irvine, CA – 3 violations:
    • Fails to establish an identity specification, as required by 21 CFR 111.70(b).
    • Fails to establish product specifications for each dietary supplement that is manufactured for the identity, purity, strength, and composition of the finished batch of dietary supplement, to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).
    • Fails to have product labels declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at sales@fdazilla.com.

(RELATED: Shine a light on your supply chain with a FREE FOOD SUPPLIER ASSESSMENT.)

About the Author

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

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