FDA Inspection
Bionatural Labs Inc.Bionatural Labs Inc. – FDA Inspection, Aug 9, 2017
Record Details
This FDA Inspection record concerns Bionatural Labs Inc., with an inspection on August 9, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · e61c7ffa-0b6a-4628-a895-5f8457f10287
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021097
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 111.83(a)Reserve sample - collect, hold
- 21 CFR 111.75(c)(2)Specifications met - test, examinations; compliance
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.303Written procedures - laboratory operations
- 21 CFR 111.25(c)Procedures - equipment - cleaning, sanitizing
- 21 CFR 111.27(d)Equipment - maintain, clean, sanitize
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
- 21 CFR 111.30(c)Equipment - automated - calibrate, inspect
- 21 CFR 111.255(b)Batch record - complete
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Other FDA inspections of Bionatural Labs Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 1, 2012 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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