Anika Therapeutics Inc — FDA Facility Profile
Anika Therapeutics Inc is an FDA-registered facility (FEI 3007093114) located in Bedford, MA, US. Registered operations: MANUFACTURE. RegDataLab tracks 11 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 13, 2026: No Action Indicated (NAI)
- Inspections on record
- 11 (8 VAI, 3 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 1, latest May 10, 2018
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 13, 2026 | No Action Indicated (NAI) | No citations listed |
| Jan 22, 2026 | Voluntary Action Indicated (VAI) | Computer control of master formula records (21 CFR 211.68(b)) Floors, walls, ceiling surfaces (21 CFR 211.42(c)(10)(i)) Procedures for sterile drug products (21 CFR 211.113(b)) Investigations of discrepancies, failures (21 CFR 211.192) |
| Aug 9, 2023 | Voluntary Action Indicated (VAI) | Equipment to control conditions (21 CFR 211.42(c)(10)(vi)) Written program not followed (21 CFR 211.166(a)) Investigations of discrepancies, failures (21 CFR 211.192) Items to cover on annual reviews (21 CFR 211.180(e)(2)) |
| Sep 21, 2017 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Floors, walls, ceiling surfaces (21 CFR 211.42(c)(10)(i)) Environmental Monitoring System (21 CFR 211.42(c)(10)(iv)) Strict control not exercised over labeling issued (21 CFR 211.125(a)) and 2 more |
| May 22, 2015 | No Action Indicated (NAI) | No citations listed |
| Dec 19, 2014 | Voluntary Action Indicated (VAI) | Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Absence of Written Procedures (21 CFR 211.100(a)) Procedures for sterile drug products (21 CFR 211.113(b)) Valid stability test methods (21 CFR 211.166(a)(3)) and 3 more |
| Nov 14, 2012 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures (21 CFR 820.100(a)) |
| Oct 31, 2011 | Voluntary Action Indicated (VAI) | No citations listed |
| Dec 22, 2010 | Voluntary Action Indicated (VAI) | Procedures not adequately established or maintained (21 CFR 820.40) Lack of or inadequate final acceptance procedures (21 CFR 820.80(d)) Calibration, Inspection, etc. Procedures Lack of or Inadequ (21 CFR 820.72(a)) Lack of or inadequate process validation (21 CFR 820.75(a)) |
| Mar 12, 2010 | Voluntary Action Indicated (VAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| May 10, 2018 | Class II | Z-2423-2018 | Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301
Product… Hyalomatrix products are susceptible to degradation as a result of the decomposition of PVC in the packaging material during sterilization… |
Facility details
- Company
- Anika Therapeutics, Inc.
- Location
- Bedford, MA (US)
- Registration Expires
- Dec 31, 2026
- Operations
- MANUFACTURE
- Source
- both