FDA Sent These 9 Warning Letters for Food Companies | October 2018

We took a snapshot of the 9 warning letters the FDA sent to food companies last month. Food violations ranged from misbranding products to failure of eliminating rodents.

From companies across the country, here they are:

• Gold Star Distribution, Inc., Minneapolis, MN – violations include but are not limited to:
  • Failed to take effective measures to exclude pests from packing and holding areas to protect against contamination of food on the premises by pests, as required by 21 CFR.
  • Failed to maintain building, fixtures, and other physical facilities of plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a).
  • Failed to store food under conditions that protect against biological, chemical, and physical contamination, as well as against deterioration of the food and the container, as required by 21 CFR 117.93.
  • Failed to properly store equipment, remove litter and waste, and cut weeds and grass that may constitute an attractant, breeding place, or harborage for pests within the immediate vicinity of the plant, as required by 117.20(a)(1).

• 5 Spoke Creamery, LLC, Goshen, NY – violations include but are not limited to:
  • Failure of equipment and utensils to be designed and of such material and workmanship as to be adequately cleanable, and failure to properly maintain equipment and utensils, as required by 21 CFR 110.40(a).
  • Failed to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing, as required by 21 CFR 110.80(b)(1).
  • The introduction or delivery for introduction into interstate commerce of misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
• Premier Produce LLC, Elizabethtown, KY – violations include but are not limited to:
  • Failed to maintain a written hazard analysis for RTE fresh-cut produce products, as required by 21 CFR 117.130(a)(2).
  • Failed to verify that sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing a likely pathogen hazard. Also, did not conduct environmental monitoring, as required by 21 CFR 117.165(a)(3).
  • Failed to establish and implement a written supply-chain program, as required by 21 CFR 117.405(a)(1).
  • Plant equipment and utensils were not so designed and of such material and workmanship as to be adequately cleanable and were not adequately maintained to protect against contamination, as required by 21 CFR 117.40(a)(1).
• Casa Pablo’s Salsa LLC, Missoula, MT – violations include but are not limited to:
  • Significant violations of the acidified food regulations (AF), Title 21, Code of Federal Regulations, Parts 108 and 114 (21 CFR 108 and 21 CFR 114).
  • Failure to maintain equipment, including utensils and food containers, in an adequate condition through appropriate cleaning and sanitizing as necessary, as required by 21 CFR 117.80(c)(1).
  • Failure to maintain buildings, fixtures, and other physical facilities in a clean and sanitary condition, and in repair adequate to prevent food from being adulterated, as required by 21 CFR 117.35(a).
  • Failure to take adequate measures to protect against the inclusion of metal or other extraneous matter in food, as required by 117.80(c)(8).
  • Failure to ensure that all persons working in direct contact with food, food-contact surfaces, and food packaging material conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR 117.10(b).
  • Significant violations of the acidified food regulations (AF), Title 21, Code of Federal Regulations, Parts 108 and 114 (21 CFR 108 and 21 CFR 114).
  • Failure to maintain equipment, including utensils and food containers, in an adequate condition through appropriate cleaning and sanitizing as necessary, as required by 21 CFR 117.80(c)(1).
• Bamboo LLC, Palmetto, GA – violations include but are not limited to:
  • Misbranded products under section 403 of the Act (21 U.S.C. § 343).
  • The introduction or delivery for introduction into interstate commerce of misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
  • Violations rendering products to be adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that they may 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.
• Original Living Coconut, LLC, Stockton, MO – violations include but are not limited to:
  • The introduction or delivery for introduction into interstate commerce of misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
• Farmers Ranchers Coop Assn, Ainsworth, NE – violations include but are not limited to:
  • Failed to adequately investigate and implement corrective actions when laboratory assays of drug components indicated that medicated feed was not in accordance with permissible limits, and to retain such records on the premises for one year as required by 21 CFR. 225.158.
  • Failed to establish and maintain adequate procedures for the identification, storage, and inventory control (receipt and use) of all Type A medicated articles and Type B medicated feeds intended for use in the manufacture of medicated feeds to aid in assuring the identity, strength, quality and purity of these drug sources as required by 21 CFR 225.142.
• Gilman Cooperative Creamery Association, Gilman, MN – violations include but are not limited to:
  • Failed to establish and use adequate procedures for all equipment used in the production and distribution of medicated feeds to avoid unsafe contamination of medicated and non-medicated feeds, 21 CFR 225.165.
  • Failed to identify and store bulk Type B medicated feeds in a manner such that their identity, strength, quality, and purity will be maintained, 21 CFR 225.142.
• Jinher, Inc., Chino, CA – violations include but are not limited to:
  • Failed to establish and follow written procedures for laboratory operations, including written procedures for the tests and examinations conducted to determine whether specifications are met, as required by 21 CFR 111.303.
  • Failed to establish specifications for 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).
  • Batch production record (BPR) did not include complete information relating to the production and control of each batch and did not include all information required in a BPR, as required by 21 CFR 111.255(b) and 21 CFR 111.260.
  • Failed to calibrate instruments and controls used in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.27(b).
  • Failed to ensure each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, has the education, training, or experience to perform the person’s assigned functions, as required by 21 CFR 111.12(c).