FDA Inspection 593399 — Watco Companies
The FDA completed an inspection of Watco Companies on Jun 30, 2009 in Saint Louis, MO. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 30, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1306 | 21 CFR 110.20(b)(7) | Screening |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3645 | 21 CFR 110.10(d) | Supervision |