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

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

By | 2018-03-29T16:36:35+00:00 March 29th, 2018|FDA Warning Letters, FDAzilla, Food|

We took a snapshot of the 6 warning letters the FDA sent to food companies this month. Food violations ranged from failing to wear beard covers to failing to exclude pests from food plants.

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

  • A.C. Calderoni & Co., Brisbane, CA – 3 violations:
    • Firm failed to have a written hazard analysis developed to determine whether there are food hazards that are reasonably likely to occur for each type of juice processed and to identify control measures that control those hazards as required by 120.7(a).
    • Firm did not have written HACCP plan that outlines controls for one or more food safety hazards that are reasonably likely to occur, as required by 21 CFR 120.8(a).
    • Firm did not monitor the conditions and practices during processing with sufficient frequency to ensure at a minimum, conformance with those conditions and practices specified in part 110 and in subpart B of part 117 of this chapter for current good manufacturing practices that include condition and cleanliness of food contact surfaces, prevention of cross-contamination form insanitary objects, maintenance of hand-washing, hand-sanitizing and toilet facilities, protection of food, food packaging material and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals and control of employee health conditions in accordance with 21 CFR 120.6(b).

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  • Bhavani Fruits and Vegetables LLC, Maspeth, NY – 4 violations:
    • Firm did not exclude pests from food plant to protect against contamination of food, as required by 21 CFR 117.35(c).
    • Firm did not maintain plant in repair adequate to keep food from becoming adulterated, as required by 21 CFR 117.35(a).
    • Firm did not store food under conditions that protect against deterioration and contamination, as required by 21 CFR 117.93.
    • Firm did not have adequate sanitary facilities and accommodations, as required by 21 CFR 117.37.
  • Anna’s Pies, LLC, Lake Charles, LA – 9 violations:
    • Failed to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c).
    • Failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7).
    • Failed to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures, as required by 21 CFR 110.20(a)(1).
    • Failed to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food and food-contact surfaces, as required by 21 CFR 110.20(b)(6).
    • Firm’s design, materials and workmanship of utensils does not allow proper cleaning and maintenance as required by 21 CFR 110.40(a).
    • Firm’s plant is not constructed in such a manner as to allow floors to be adequately cleaned and kept clean and kept in good repair as required by 21 CFR 110.20(b)(4).
    • Firm employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time their hands may have become soiled or contaminated as required by 21 CFR 110.10(b)(3).
    • Failed to provide safety-type light bulbs and lighting fixtures suspended over exposed food as required by 21 CFR 110.20(b)(5).
    • Failed to wear beard covers where appropriate as required by 21 CFR 110.10(b)(6).
  • Starlight Desserts Inc., Seattle, WA – 6 violations:
    • Failed to take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c).
    • Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility at any time that their hands may have become soiled or contaminated, as required by 21 CFR 110.10(b)(3).
    • Failed to clean all food-contact surfaces, including utensils and food-contact surfaces of equipment as frequently as necessary to protect against contamination of food, as required by 21 CFR 110.35(d).
    • Failed to maintain building fixtures and other physical facilities of the plant in a sanitary condition and in sufficient repair to prevent food from being adulterated, as required by 21 CFR 110.35(a).
    • Failed to provide adequate and readily accessible toilet facilities maintained in a sanitary condition, as required by 21 CFR 110.37(d)(1).
    • Failed to ensure the plant and facilities are constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair, as required by 21 CFR 110.20(b)(4).
  • Remnant Inc. DBA The Donut Stop, Shenandoah, IA – 6 violations:
    • Failed to perform filling, assembling, packaging, and other operations in such a manner that protects food from becoming contaminated as required by 21 CFR 110.80(b)(13).
    • Failed to maintain finished food containers in an acceptable condition through appropriate cleaning and sanitizing, as required by 21 CFR 110.80(b)(1).
    • Failed to handle work-in process to protect it from contamination, as required by 21 CFR 110.80(b)(5).
    • Failed to clean food-contact surfaces and utensils as frequently as necessary to protect against contamination of food, as required by 21 CFR 110.35(d).
    • Failed to maintain buildings, fixtures, or other physical facilities in a sanitary condition, as required by 21 CFR 110.35(a).
    • Failed to ensure all persons working in direct contact with food conform to hygienic practices while on duty to product against contamination of food by employees wearing suitable outer garments that protect against contamination of food as required by 21 CFR 110.10(b)(1).
  • Carol Bond Health Foods, Inc., Liberty, TX – 5 violations:
    • 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, as required by 21 CFR 111.103 and 111.140(b)(1).
    • Failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplement that firm distributes, as required by 21 CFR 111.83(a).
    • Failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR 111.503.
    • Failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553, and for the review and investigation of product complaints, as required by 21 CFR 111.560.
    • Failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453.

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About the Author

Paul Brooks

Paul Brooks is the lead FSMA/Food Business Development Representative at FDAzilla.

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