FDA Inspection 1304024 — Aphena Pharma Solutions - Maryland, LLC
The FDA completed an inspection of Aphena Pharma Solutions - Maryland, LLC on February 20, 2026 in Easton, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 20, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Easton, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |