FDA Inspection 764956 — Advanced Apothecaries, Inc.
The FDA completed an inspection of Advanced Apothecaries, Inc. on Jan 26, 2012 in Fort Smith, AR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 26, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Smith, AR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |