FDA Inspection 1300772 — American Regent, Inc.
The FDA completed an inspection of American Regent, Inc. on January 29, 2026 in New Albany, OH. 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
- January 29, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- New Albany, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |