Home / CFR sections / 21 CFR 114.100(b)

21 CFR 114.100(b) citations

Processing and production - required information

FDA investigators cited 21 CFR 114.100(b) 582 times at 450 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Sep 16, 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
202627
202530
202429
202317
202222
202110
202012
201929
201829
201745

Recent citations

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

Inspection endedFacilityCountryObservation
Sep 16, 2026Gourmet Recipe Experts, Inc.United StatesYou did not maintain production records showing adherence to the scheduled process.
Sep 1, 2026Four In One, LLCUnited StatesYou did not maintain processing records showing adherence to the scheduled process.
Aug 31, 2026Dongseo Wellbeing CorporationKorea (the Republic of)You did not maintain production records showing adherence to the scheduled process.
Aug 31, 2026Zion Organic Inc.United StatesYou did not maintain processing and production records showing adherence to the scheduled process.
Jul 28, 2026TAIZHOU JINSHA FOODS CO., LTD.ChinaThe production records do not contain sufficient additional information such as product code and container size to permit a public health hazard evaluation of the processes applied to each lot and batch of production.
Jul 16, 2026Ove Water Services, Inc.United StatesYou did not maintain processing and production records showing adherence to the scheduled process.
Jun 25, 2026John Henry's Food Products, IncUnited StatesYou did not maintain processing and production records showing adherence to the scheduled process.
Jun 2, 2026Bare Honey, LLCUnited StatesYou did not maintain processing and production records showing adherence to the scheduled process.
May 28, 2026Cry Baby Craigs LLCUnited StatesYou did not maintain processing and production records showing adherence to the scheduled process.
May 28, 2026PS Seasoning & Spices, Inc.United StatesYou did not maintain processing records showing adherence to the scheduled process.
May 26, 2026G S E FOOD ENTERPRISES LLCUnited StatesYou did not maintain processing and production records showing adherence to the scheduled process.
May 6, 2026Michael's Exotic Peppers LLCUnited StatesYou did not maintain processing records showing adherence to the scheduled process.
Apr 22, 2026Premier Foods, LLCUnited StatesYou did not maintain processing and production records showing adherence to the scheduled process.
Apr 14, 2026Stauffer's Country Kitchen LLCUnited StatesYou did not maintain processing and production records showing adherence to the scheduled process.
Mar 31, 2026The Karma Sauce Company LLCUnited StatesYou did not maintain production records showing adherence to the scheduled process.
Mar 16, 2026Stuart's Cajun Pickles II. LLCUnited StatesYou did not maintain processing and production records showing adherence to the scheduled process.
Feb 27, 2026Fire Horse International LLCUnited StatesYou did not maintain processing and production records showing adherence to the scheduled process.
Feb 27, 2026Single Variety Ltd.United KingdomYou did not maintain production records showing adherence to the scheduled process.
Jan 30, 2026Trifecta Brands LLCUnited StatesYou did not maintain processing records showing adherence to the scheduled process.
Jan 29, 2026Space Coast SaucesUnited StatesYou did not maintain processing records showing adherence to the scheduled process.
Jan 28, 2026MDM Innovations, LLCUnited StatesYou did not maintain processing and production records showing adherence to the scheduled process.
Jan 7, 2026Tatemada LLCUnited StatesYou did not maintain processing and production records showing adherence to the scheduled process.
Dec 19, 2025SARDES GIDA SAN VE TARIM URUNLERI TIC.ITH.IHR.LTD. STITurkeyYou did not maintain production records showing adherence to the scheduled process.
Dec 18, 2025FC Sauces LLCUnited StatesYou did not maintain processing and production records showing adherence to the scheduled process.
Oct 29, 2025Frantoio Oleario Quattrociocchi AmericoItalyYou did not maintain processing records showing adherence to the scheduled process.

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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.