FDA 483 - Environmental Tectonics Corp - August 01, 2019

Environmental Tectonics Corp, a medical device manufacturer in Southampton, PA, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate documentation of corrective and preventive actions, failure to properly process MDR reportable events as complaints, and lack of validation for a critical sterilization process. The firm also had issues with document control, missing device history records, and absence of Unique Device Identifiers for distributed products.