Home / CFR sections / 21 CFR 111.255(a)

21 CFR 111.255(a) citations

Batch record - every batch

FDA investigators cited 21 CFR 111.255(a) 333 times at 281 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Sep 2, 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
202621
202523
202411
202315
202218
20217
202014
201915
201833
201727

Recent citations

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

Inspection endedFacilityCountryObservation
Sep 2, 2026BioCorp Nutrition LabsUnited StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Aug 27, 2026Karuna Kava And Tea LLCUnited StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Aug 11, 2026Beauty & Spa ConceptsUnited StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Aug 11, 2026SUNFLOWER NUTRACEUTICALS LLCUnited StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Jun 11, 2026Professional Business Associates IncUnited StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Jun 11, 2026Trinity Natural Health & Pain Management,Inc.United StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Apr 17, 2026Total Life ChangesUnited StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Apr 2, 2026Wellnov Supplements LLCUnited StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Mar 27, 2026American Pharma Mfg. Inc.United StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Mar 16, 2026Albanese Confectionery Group, Inc.United StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Mar 16, 2026CHACHITO.COM CORPUnited StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Mar 12, 2026Painted Outlaw Ranch LLCUnited StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Feb 26, 2026Nutrition DepotUnited StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Feb 17, 2026UNIS-BIO PHARMA LLCUnited StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Feb 2, 2026Akeso Health Sciences, LLCUnited StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Jan 15, 2026Focus NutritionUnited StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Nov 6, 2025Professional Nutritionals, LLCUnited StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Oct 30, 2025Nutraceutic Labs IncUnited StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Oct 27, 2025NPC CorporationUnited StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Oct 22, 2025Marine Minerals, Inc.United StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Oct 16, 2025Nature's Elements, Inc.United StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Sep 26, 2025A6 Supplements, Inc.United StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Sep 24, 2025NuPack IncUnited StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Aug 28, 20252629168 Ontario Inc.CanadaYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.
Aug 7, 2025Metta Hemp CompanyUnited StatesYou did not prepare a batch production record every time you manufactured a batch of dietary supplement.

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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.