FDA Inspection 638122 — Apotheca Supply, Inc
The FDA completed an inspection of Apotheca Supply, Inc on January 6, 2010 in Decatur, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 6, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Decatur, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1222 | 21 CFR 211.67(b)(4) | Cleaning SOPs/equipment identification |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |