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