FDA Inspection
Biotek, Inc.Biotek, Inc. – FDA Inspection, Aug 24, 2017
Record Details
This FDA Inspection record concerns Biotek, Inc., with an inspection on August 24, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Person
- Lavender M. Huskey
View Company Profile
ID · c03c9415-edbd-4cfc-8bc0-d372319d3222
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1023313
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 111.83(a)Reserve sample - collect, hold
- 21 CFR 111.453Written procedures - holding
- 21 CFR 111.403Written procedures - labeling operations
- 21 CFR 111.403Written procedures -packaging operations
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.503Written procedures - returned dietary supplement
- 21 CFR 111.70(d)Specifications - labels, packaging
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.70(f)Specifications - product received for packaging, labeling
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Other FDA inspections of Biotek, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 20, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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