FDA Inspection 1214830 — Anika Therapeutics, Inc.
The FDA completed an inspection of Anika Therapeutics, Inc. on Aug 9, 2023 in Bedford, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 9, 2023
- Fiscal Year
- 2023
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Bedford, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |