# FDA 483 - Anika Therapeutics, Inc. - August 09, 2023

Source: https://www.keypedia.com/records/483/anika-therapeutics-inc/07f93da9-af58-4dab-81db-f0d649fbbf2f

> FDA 483 for Anika Therapeutics, Inc. on August 09, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Anika Therapeutics, Inc.
- Inspection Date: 2023-08-09
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Anika Therapeutics, Inc. in Bedford, MA was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, including failures in following stability testing programs, thoroughly investigating product complaints, maintaining aseptic processing areas, and conducting annual product reviews for its Hyvisc product. These issues indicate a lack of adherence to established procedures and regulatory requirements.

## Related Documents

- [483 - 2017-09-21](https://www.keypedia.com/records/483/anika-therapeutics-inc/0c3395ae-f12a-40e0-941a-4b06cab3e0e6)
- [483 - 2026-01-22](https://www.keypedia.com/records/483/anika-therapeutics-inc/6ee0397c-b2e8-4c3d-b45d-dd3386d4b81d)

## Related Officers

- [Investigator](https://www.keypedia.com/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)

Company: https://www.keypedia.com/companies/anika-therapeutics-inc/3499e53d-9858-4f0d-b826-b4a4a05ac3e7

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94