FDA Inspection
Biotron Laboratories, LLCBiotron Laboratories, LLC – FDA Inspection, Dec 23, 2019
Record Details
This FDA Inspection record concerns Biotron Laboratories, LLC, with an inspection on December 23, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Biotron Laboratories, LLC
- Inspection Date
- December 23, 2019
- Product Type
- Food/cosmetics
View Company Profile
ID · 27f03b59-10cf-4113-8775-da7306783b25
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1113600
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
7- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.75(h)Tests, examinations - scientifically valid
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.35(b)(3)Instruments, controls; calibrate date, reference std, method
- 21 CFR 111.210(f)Master manufacturing record theoretical and expected yield
- 21 CFR 111.210(d)Master manufacturing record - Supplemental Facts
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biotron Laboratories, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2024 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| September 24, 2014 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Biotron Laboratories, LLC
- FDA Inspection 1249345 - 2024-09-11
- FDA Inspection 896943 - 2014-09-24
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