FDA Inspection 837987 — Aphena Pharma Solutions - Maryland, LLC
The FDA completed an inspection of Aphena Pharma Solutions - Maryland, LLC on June 27, 2013 in Easton, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 27, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Easton, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1509 | 21 CFR 211.122(h) | Printing devices |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2035 | 21 CFR 211.194(e) | Stability testing records not included |