FDA 483 - CooperSurgical, Inc. - July 15, 2021

CooperSurgical, Inc. in Trumbull, CT, a medical device manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included uncontrolled labeling and packaging operations leading to multiple product recalls, failure to submit Medical Device Reports within the required 30-day timeframe, and inadequate procedures for handling nonconforming products. Additionally, the firm lacked established procedures for controlling environmental conditions, specifically clean room wall cleaning.