FDA Inspection
Bio-Tech Pharmacal, IncBio-Tech Pharmacal, Inc – FDA Inspection, Apr 11, 2025
Record Details
This FDA Inspection record concerns Bio-Tech Pharmacal, Inc, with an inspection on April 11, 2025, issued by the Dallas District Office, covering foods & cosmetics.
View Company Profile
ID · 2cbcf6f9-13f1-48a4-b360-9542e5ca6596
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1266502
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling, and Economics
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 111.75(a)(2)Appropriate tests, examinations; certificate of analysis
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 21, 2021 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 14, 2016 | VAI | 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 1141479 - 2021-04-21
- FDA Inspection 985162 - 2016-09-14
- FDA Inspection 985160 - 2016-09-14
- FDA Inspection 707926 - 2011-02-02
- FDA Inspection 550126 - 2008-11-14
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.