FDA Inspection 964161 — A.P. Deauville, LLC
The FDA completed an inspection of A.P. Deauville, LLC on February 1, 2016 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
- February 1, 2016
- Fiscal Year
- 2016
- 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 |
| 1384 | 21 CFR 211.101(c) | Weighing/measuring/subdividing supervision |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 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 |