Home / CFR sections / 21 CFR 117.35(a)

21 CFR 117.35(a) citations

Sanitary operations - Plant sanitation

FDA investigators cited 21 CFR 117.35(a) 2,355 times at 1,894 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
20272
2026346
2025316
2024257
2023284
2022255
2021120
2020136
2019315
2018249

Recent citations

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

Inspection endedFacilityCountryObservation
Oct 7, 2026Bader Enterprise IncUnited StatesYou did not maintain your plant in adequate repair.
Oct 7, 2026Tam An 2, Inc. (Formerly Rach Gia, Inc.)United StatesYou did not maintain your plant in a clean and sanitary condition and in adequate repair.
Sep 25, 2026MADEMOISELLE COLETTE INCUnited StatesYou did not maintain your plant in adequate repair.
Sep 24, 2026Royal Gourmet House, IncUnited StatesYou did not maintain your plant in a clean and sanitary condition.
Sep 18, 20261808 BASTROP LLCUnited StatesYou did not maintain your plant in a clean and sanitary condition and in adequate repair.
Sep 18, 2026BAPS ShayonaUnited StatesYou did not clean and sanitize your utensils or equipment in a manner that protects against contamination.
Sep 11, 2026El Ruisenor De Mexico, Inc.United StatesYou did not maintain your plant in adequate repair.
Sep 10, 2026New Chicago Wholesale Inc.United StatesYou did not maintain your plant in a clean and sanitary condition.
Sep 3, 2026Coffee Baking CoUnited StatesYou did not maintain your plant in a clean and sanitary condition.
Sep 1, 2026Meherrin Chemical And AgricultureUnited StatesYou did not maintain your plant in a clean and sanitary condition.
Aug 31, 2026An Xuyen Bakery, Inc.United StatesYou did not maintain your plant in adequate repair.
Aug 31, 2026J.K Patisserie & Bakery LLCUnited StatesYou did not maintain your plant in a clean and sanitary condition and in adequate repair.
Aug 31, 2026J.K Patisserie & Bakery LLCUnited StatesYou did not clean and sanitize your utensils or equipment in a manner that protects against contamination.
Aug 28, 2026Fresh Gourmet Cuisine Corp.United StatesYou did not clean and sanitize your utensils or equipment in a manner that protects against contamination.
Aug 28, 2026Taylor Farms Illinois Inc.United StatesYou did not maintain your plant in adequate repair.
Aug 27, 2026Distinct Indulgence, IncUnited StatesYou did not maintain your plant in a clean and sanitary condition and in adequate repair.
Aug 27, 2026The Molecular Mexican Inc.United StatesYou did not clean and sanitize your utensils or equipment in a manner that protects against contamination.
Aug 26, 2026Mickey's Pastry Shop IncUnited StatesYou did not clean and sanitize your utensils or equipment in a manner that protects against contamination.
Aug 24, 2026Suyat Enterprises, LLCUnited StatesYou did not clean and sanitize your utensils or equipment in a manner that protects against contamination.
Aug 24, 2026The Icee CompanyUnited StatesYou did not maintain your plant in adequate repair.
Aug 21, 2026FIVE GOODS INCUnited StatesYou did not maintain your plant in a clean and sanitary condition and in adequate repair.
Aug 21, 2026Wako Inflight Service IncUnited StatesYou did not maintain your plant in adequate repair.
Aug 20, 2026Skh Trading Inc.United StatesYou did not maintain your plant in a clean and sanitary condition and in adequate repair.
Aug 19, 2026Central America Products CorporationUnited StatesYou did not clean and sanitize your utensils or equipment in a manner that protects against contamination.
Aug 18, 2026Beth's Farm Kitchen LLCUnited StatesYou did not clean and sanitize your utensils or equipment in a manner that protects against contamination.

Search more

Search every Form 483 citation by company with the FDA 483 search, see all frequently cited CFR sections, or check one supplier with the free FDA compliance check.

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