# FDA WARNING_LETTER - Anika Therapeutics, Inc. - March 21, 2008

Source: https://www.keypedia.com/records/warning_letter/anika-therapeutics-inc/87a7b3fb-1294-40d6-b531-30e69ad8899c

> FDA WARNING_LETTER for Anika Therapeutics, Inc. on March 21, 2008. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Anika Therapeutics, Inc.
- Inspection Date: 2008-03-21
- Product Type: Devices
- Office Name: New England District Office
- Summary: On July 2, 2008, the FDA issued a Warning Letter to Anika Therapeutics, Inc. following a March 10-21, 2008 inspection of their Woburn, MA facility. The inspection revealed that the firm's medical devices (Amvisc, Amvisc Plus, Staarvisc II, Shellgel, Orthovisc) were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulations (21 C.F.R. Part 820). The animal drug Hyvisc was also found adulterated under 21 U.S.C. § 351(a)(2)(B) for failing to meet cGMP regulations (21 C.F.R. Part 211).

Key violations included:
1.  **Inadequate Quality System (21 C.F.R. § 820.20):** Management failed to ensure an effective quality system, evidenced by the quality department not observing critical manufacturing steps, lack of environmental monitoring, and absence of a required handwashing sink outside the sterile gowning room.
2.  **Process Validation Failures (21 C.F.R. § 820.75(a)):** Media fills did not fully simulate routine aseptic manufacturing, critical area

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