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21 CFR 117.80(c) citations

Process Control Measures

FDA investigators cited 21 CFR 117.80(c) 1,446 times at 1,284 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Oct 7, 2026. 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
20271
2026165
2025192
2024184
2023143
2022153
202189
202096
2019182
2018187

Recent citations

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

Inspection endedFacilityCountryObservation
Oct 7, 2026Tam An 2, Inc. (Formerly Rach Gia, Inc.)United StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for growth or survival of microorganisms, contamination of food and deterioration of food.
Sep 23, 2026The H.T. Hackney CompanyUnited StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for growth or survival of microorganisms and deterioration of food.
Sep 17, 2026Digestive Diet, Inc.United StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for allergen cross-contact.
Sep 11, 2026Broad Ripple Chip Co.United StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for allergen cross-contact.
Sep 11, 2026El Ruisenor De Mexico, Inc.United StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food.
Sep 11, 2026Nestle Nederland BVNetherlandsYou did not conduct operations under conditions and controls necessary to minimize the potential for growth or survival of microorganisms and contamination of food.
Sep 4, 2026E. Formella & Sons, Inc.United StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for growth or survival of microorganisms.
Sep 4, 2026The Brownie Baker Inc.United StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food.
Sep 2, 2026Gold Star Foods, Inc.United StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for deterioration of food.
Sep 1, 2026Allied Old English,IncUnited StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food.
Sep 1, 2026Four In One, LLCUnited StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food and deterioration of food.
Aug 31, 2026Dae Won Food USA Inc.United StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food.
Aug 31, 2026J.K Patisserie & Bakery LLCUnited StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for growth or survival of microorganisms, allergen cross-contact and contamination of food.
Aug 24, 2026Gloria's Pantry Inc.United StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for growth or survival of microorganisms.
Aug 21, 2026FIVE GOODS INCUnited StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for growth or survival of microorganisms.
Aug 20, 2026Laticinios Tirolez LtdaBrazilYou did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food.
Aug 19, 2026Jasper Wyman & SonUnited StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food.
Aug 17, 2026Prince Bakery IncUnited StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for allergen cross-contact and contamination of food.
Aug 13, 2026Dady Premier Catering LLCUnited StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for allergen cross-contact and contamination of food.
Aug 3, 2026Get Chia, Inc.United StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food.
Jul 29, 2026Hausbeck Pickle Company, Inc.United StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for growth or survival of microorganisms.
Jul 29, 2026Perfect 85 Degrees C, Inc.United StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for allergen cross-contact.
Jul 24, 2026Bonfire Burritos Distribution CenterUnited StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for growth or survival of microorganisms.
Jul 24, 2026DDC CPL, LLCUnited StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food.
Jul 24, 2026Harvester Foods Corp.United StatesYou did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food.

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