Anika Therapeutics, Inc.
⚠️ High Risk
FEI: 3007093114 • Bedford, MA • UNITED STATES
FEI Number
3007093114
Location
Bedford, MA
Country
UNITED STATESAddress
32 Wiggins Ave, , Bedford, MA, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/21/2025 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Northeast Imports (DNEI) | |
| 1/27/2025 | 62GDY99ANTI-INFLAMMATORY N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/18/2023 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Southeast Imports (DSEI) | |
| 5/17/2023 | 87MOZACID, HYALURONIC, INTRAARTICULAR | 237NO PMA | Division of Northeast Imports (DNEI) |
| 5/17/2023 | 87MOZACID, HYALURONIC, INTRAARTICULAR | 237NO PMA | Division of Northeast Imports (DNEI) |
| 4/26/2023 | 87MOZACID, HYALURONIC, INTRAARTICULAR | 237NO PMA | Division of Northeast Imports (DNEI) |
| 11/12/2020 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Northern Border Imports (DNBI) | |
| 11/12/2020 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Northern Border Imports (DNBI) | |
| 4/26/2018 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Southeast Imports (DSEI) | |
| 4/26/2018 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Southeast Imports (DSEI) | |
| 3/8/2018 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Southeast Imports (DSEI) | |
| 10/5/2015 | 87MOZACID, HYALURONIC, INTRAARTICULAR | 2480RXPERSONAL | New Orleans District Office (NOL-DO) |
| 9/19/2008 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 5/24/2006 | 89MOZACID, HYALURONIC, INTRAARTICULAR | 341REGISTERED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Anika Therapeutics, Inc.'s FDA import refusal history?
Anika Therapeutics, Inc. (FEI: 3007093114) has 14 FDA import refusal record(s) in our database, spanning from 5/24/2006 to 11/21/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Anika Therapeutics, Inc.'s FEI number is 3007093114.
What types of violations has Anika Therapeutics, Inc. received?
Anika Therapeutics, Inc. has been cited for 9 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Anika Therapeutics, Inc. come from?
All FDA import refusal data for Anika Therapeutics, Inc. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.