FDA Inspection
Bionatal, LLCBionatal, LLC – FDA Inspection, Aug 21, 2025
Record Details
This FDA Inspection record concerns Bionatal, LLC, with an inspection on August 21, 2025, issued by the Dallas District Office, covering foods & cosmetics.
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ID · 46804c40-263f-4435-97ce-d6e8a36b6024
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1279064
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling, and Economics
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 111.70(b)Specifications - components
- 21 CFR 111.83(a)Reserve sample - collect, hold
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.75(i)Corrective action plan
- 21 CFR 111.70(d)Specifications - labels, packaging
- 21 CFR 111.70(e)Specifications - finished dietary supplement
- 21 CFR 111.103Written procedures - establish; quality control operations
- 21 CFR 111.75(c)Specifications met - verify; finished batch
- 21 CFR 111.210Master manufacturing record - record requirements
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