FDA Inspection 1025686 — A.P. Deauville, LLC
The FDA completed an inspection of A.P. Deauville, LLC on September 19, 2017 in Easton, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 19, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Easton, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1384 | 21 CFR 211.101(c) | Weighing/measuring/subdividing supervision |
| 17851 | 21 CFR 212.60(c) | Analytical methods |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |