FDA Inspection 906074 — Anika Therapeutics, Inc.
The FDA completed an inspection of Anika Therapeutics, Inc. on Dec 19, 2014 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). 7 citations were issued during this inspection. Product area: Veterinary.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 19, 2014
- Fiscal Year
- 2015
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Bedford, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |