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

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