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21 CFR 117.145(a) citations

Sanitation Controls Monitoring Proced: Establish Implement

FDA investigators cited 21 CFR 117.145(a) 402 times at 297 facilities in the inspection citations FDA publishes, most recently in an inspection that ended May 13, 2022. A citation is an observation listed on Form FDA 483 at the end of an inspection; it is not a final agency decision.

Citations by fiscal year

FDA fiscal yearCitations
202255
202162
202093
2019125
201850
201717

Recent citations

The latest inspections that cited this section. Facility names link to each facility's FDA record.

Inspection endedFacilityCountryObservation
May 13, 2022McClancy Foods And Flavors LLCUnited StatesYou did not implement adequate written procedures for monitoring allergen controls.
May 12, 2022Tropical Bakery Wholesale CorpUnited StatesYou did not implement adequate written procedures for monitoring allergen controls.
May 6, 2022AGRONIC FOOD PVT. LTDIndiaYou did not establish and implement adequate written procedures for monitoring allergen controls.
May 6, 2022Stir Foods, LLC.United StatesYou did not establish and implement adequate written procedures for monitoring allergen controls.
Apr 29, 2022King Henry's, Inc.United StatesYou did not establish and implement adequate written procedures for monitoring your controls.
Apr 27, 2022Peggy Lawton Kitchens, Inc.United StatesYou did not establish and implement adequate written procedures for monitoring your controls.
Apr 26, 2022JonnyPops LLCUnited StatesYou did not establish and implement adequate written procedures for monitoring sanitation controls.
Apr 8, 2022Diaspora Tea & Herb Co., LLCUnited StatesYou did not implement adequate written procedures for monitoring allergen controls.
Apr 8, 2022Laura Chenel Chevre, Inc.United StatesYou did not implement adequate written procedures for monitoring process controls.
Apr 7, 2022Gracie's Kitchens Inc.United StatesYou did not establish adequate written procedures for monitoring sanitation controls.
Apr 7, 2022QualiTech, LLCUnited StatesYou did not implement adequate written procedures for monitoring sanitation controls.
Apr 7, 2022United Dairy Farmers IncUnited StatesYou did not implement adequate written procedures for monitoring allergen controls.
Apr 5, 2022Wagner Provisions Co., IncUnited StatesYou did not establish and implement adequate written procedures for monitoring process controls.
Mar 31, 2022Annies Bakery, Inc.United StatesYou did not establish and implement adequate written procedures for monitoring process controls.
Mar 25, 2022So-Pak-Co ProcessingUnited StatesYou did not establish and implement adequate written procedures for monitoring sanitation controls.
Mar 24, 2022CHICAGO SWEET CONNECTION, INC.United StatesYou did not implement adequate written procedures for monitoring allergen controls.
Mar 24, 2022Fruit Fresh Up, Inc.United StatesYou did not establish and implement adequate written procedures for monitoring process controls.
Mar 22, 2022Domenico's Los Angeles, LLCUnited StatesYou did not establish and implement adequate written procedures for monitoring process controls.
Mar 18, 2022National Food Industries, LLCUnited Arab EmiratesYou did not implement adequate written procedures for monitoring process controls.
Mar 11, 2022Charanga Catering, LLCUnited StatesYou did not implement adequate written procedures for monitoring sanitation controls.
Mar 10, 2022Bagel King Wholesale Bakery LLCUnited StatesYou did not establish adequate written procedures for monitoring sanitation controls.
Mar 7, 2022Garden-Fresh Foods, Inc.United StatesYou did not establish and implement adequate written procedures for monitoring process controls.
Mar 7, 2022Garden-Fresh Foods, Inc.United StatesYou did not establish and implement adequate written procedures for monitoring allergen controls.
Mar 4, 2022Molto Gourmet LLCUnited StatesYou did not implement adequate written procedures for monitoring sanitation controls.
Mar 4, 2022Todd's BBI International, IncUnited StatesYou did not establish and implement adequate written procedures for monitoring process controls.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.