FDA Inspection 1028450 — Apotheca, Inc.
The FDA completed an inspection of Apotheca, Inc. on October 11, 2017 in Phoenix, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 11, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Phoenix, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |