FDA Inspection 557687 — Abbey Color Incorporated
The FDA completed an inspection of Abbey Color Incorporated on January 20, 2009 in Philadelphia, PA. 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
- January 20, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |