FDA Inspection
Bio-Tech Pharmacal, IncBio-Tech Pharmacal, Inc – FDA Inspection, Sep 14, 2016
Record Details
This FDA Inspection record concerns Bio-Tech Pharmacal, Inc, with an inspection on September 14, 2016, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Bio-Tech Pharmacal, Inc
- Inspection Date
- September 14, 2016
- Product Type
- Food/cosmetics
View Company Profile
ID · d14e0d1f-7b17-4bcc-bd2a-9beb6f62ac6a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 985162
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
2- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.105Quality control - ensure quality; package, labeled, master record
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bio-Tech Pharmacal, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2025 | VAI | Dallas District Office | Food Composition, Standards, Labeling, and Economics |
| April 21, 2021 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 14, 2016 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 2, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 14, 2008 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bio-Tech Pharmacal, Inc
- FDA Inspection 1266502 - 2025-04-11
- FDA Inspection 1141479 - 2021-04-21
- FDA Inspection 985160 - 2016-09-14
- FDA Inspection 707926 - 2011-02-02
- FDA Inspection 550126 - 2008-11-14
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