Home / CFR sections / 21 CFR 111.205(a)

21 CFR 111.205(a) citations

Master manufacturing record - unique formulation

FDA investigators cited 21 CFR 111.205(a) 943 times at 751 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Sep 30, 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
202667
202571
202461
202349
202245
202122
202033
201956
201864
201774

Recent citations

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

Inspection endedFacilityCountryObservation
Sep 30, 2026Wand Packaging Inc.United StatesYou did not prepare a written master manufacturing record for each batch size of a dietary supplement that you manufactured.
Sep 22, 2026Remedy's Health Food, Inc.United StatesYou did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured.
Sep 16, 2026TAKA USA, INC.United StatesYou did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured.
Sep 15, 2026NPRI-O2P, LLCUnited StatesYou did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured.
Aug 12, 2026Ele Chocolates, LLCUnited StatesYou did not follow a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured.
Aug 11, 2026Beauty & Spa ConceptsUnited StatesYou did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured.
Aug 11, 2026SUNFLOWER NUTRACEUTICALS LLCUnited StatesYou did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured.
Aug 5, 2026Sreedhareeyam Farmherbs IndiaIndiaYou did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured.
Aug 4, 2026KangyacareUnited StatesYou did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured.
Jul 31, 2026Nutrixen Healthy LLCUnited StatesYou did not prepare a written master manufacturing record.
Jul 16, 2026Streamline Manufacturing, LLCUnited StatesYou did not prepare a written master manufacturing record for each batch size of a dietary supplement that you manufactured.
Jul 14, 2026Krakatoa Inc (FL)United StatesYou did not prepare a written master manufacturing record for each batch size of a dietary supplement that you manufactured.
Jul 9, 2026Blue Mountain Labs LLCUnited StatesYou did not prepare a written master manufacturing record for each batch size of a dietary supplement that you manufactured.
Jul 9, 2026Total Nutrition Partners, LLCUnited StatesYou did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured.
Jun 24, 2026Life Science Labs Manufacturing LLCUnited StatesYou did not prepare a written master manufacturing record for each batch size of a dietary supplement that you manufactured.
Jun 24, 2026Provision Health Corp.United StatesYou did not prepare a written master manufacturing record for each batch size of a dietary supplement that you manufactured.
Jun 18, 2026NutriCrafters LLCUnited StatesYou did not prepare a written master manufacturing record for each batch size of a dietary supplement that you manufactured.
Jun 11, 2026Professional Business Associates IncUnited StatesYou did not prepare a written master manufacturing record.
Jun 10, 2026E2E PHARMA LLCUnited StatesYou did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured.
Jun 5, 2026Life And Health Alternatives Inc.United StatesYou did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured.
May 29, 2026Pharmachem Laboratories LLCUnited StatesYou did not prepare a written master manufacturing record for each batch size of a dietary supplement that you manufactured.
May 26, 2026Ace Packwell Pty., Ltd.AustraliaYou did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured.
May 22, 2026Apex Nutra LLCUnited StatesYou did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured.
May 22, 2026Brand Elevation Partners, LLCUnited StatesYou did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured.
May 18, 2026Price Pharmaceuticals, LLC D.B.A. Just Move SupplementsUnited StatesYou did not prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured.

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.