FDA Inspection 985162 — Bio-Tech Pharmacal, Inc
The FDA completed an inspection of Bio-Tech Pharmacal, Inc on September 14, 2016 in Fayetteville, AR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 14, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Fayetteville, AR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |