FDA Inspection 773333 — COLONIAL DAMES CO LTD
The FDA completed an inspection of COLONIAL DAMES CO LTD on March 20, 2012 in Commerce, CA. 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
- March 20, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Commerce, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |