FDA Inspection 820159 — A.P. Deauville, LLC
The FDA completed an inspection of A.P. Deauville, LLC on March 4, 2013 in Easton, 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
- March 4, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Easton, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |