Anika Therapeutics Gets Warning Letter

The FDA cited Anika Therapeutics, which supplies ophthalmic and joint health products to Bausch & Lomb and Johnson & Johnson subsidiary DePuy Mitek, for not having a hand-washing sink outside its sterile gowning room after the firm’s quality assurance (QA) department deemed it unnecessary.

“Because of your QA management’s decision that the lack of a hand washing sink in such basic septic manufacturing operations is acceptable, we are concerned that an effective quality system has not been implemented and maintained,” the FDA told the company in a July 2 warning letter, which was posted recently.

The letter cited Anika for quality systems violations for viscosupplementation product Orthovisc, a hyaluronic acid solution injected into joint spaces. DePuy markets the device in the U.S.

Production operations for Amvisc and Amvisc Plus, which are general-purpose viscoelastics used during cataract procedures, also were cited. The products are marketed by Bausch & Lomb.

Another concern the FDA raised was how the firm handled complaints. “We observed that when you receive a complaint, you are not contacting the original complainant to obtain the information required to make a thorough investigation. Instead you are only dealing with the distributor, even though you are provided with the complainant’s name,” the FDA says in the letter.

Information concerning the number of events, the final diagnosis and specific treatment were not always obtained. “Without this information, it is difficult to make a conclusion that further investigation is not warranted or an event is not reportable under 21 C.F.R. Part 803,” the letter says.

The company said it was cooperating with the FDA, and a plan to remediate the issues has been developed. Product quality is its highest concern, and it is committed to investing in the best quality systems, Anika said.

SOURCE: FDANEWS