Anika Therapeutics, the maker of <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">medical devices used to promote the protection and healing of bone, cartilage and soft tissue, has received a Food & Drug Administration (FDA) warning letter about manufacturing problems uncovered during a March inspection of its plant in Woburn, Massachusetts.Â Â Ankika makes Amvisc, Amvisc Plus, Staarvisc II, Shellgel and Orthovisc medical devices, as well as the Hyvisc prescription animal drug at the Woburn plant.
In its letter dated July 2, the FDA said that an inspection of the Anika plant revealed that devices made there were adulterated because the methods, facilities and controls used for their manufacture, packing, storage, or installation are not in conformity with the current Good Manufacturing Practice requirements.Â Among other things, inspectors visiting the plant in March found that:
- The quality department did not observe critical steps in the manufacturing process ofÂ products or take environmental monitoring samples to monitor the aseptic manufacturing operations.Â Inspectors also observed that there was not a basic hand washing sink outside the plant’s sterile gowning room, even though Anika’s own standard operating procedure requires hand washing to be completed.
- The environmental monitoring program did not provide meaningful information on the quality of the aseptic processing environment and ancillary areas used in the manufacture of Amvisc, Staarvisc II, Shellgel, Amvisc Plus, and Orthovisc.
- Failure to establish and maintain procedures for implementing corrective and preventive actions, including investigating the cause of nonconformities relating to product, processes, and the quality system.
- Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
- Failure to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality.
Anika has 15 working days from the date it received the letter to respond to the FDA.Â The letter stated that failure to promptly correct all violations could result in legal action being initiated against Anika by the FDA without further notice. These actions include, but are not limited to, seizure, and/or injunction and, with respect to the device violations described in the letter, could include civil money penalties.