The FDA handed Endotec a Form 483 after a December inspection of its Santa Fe Springs, California facility brought to light validation failures and corrective and preventive action shortcomings.
The firm produced hip, knee and shoulder orthopedic implants that were sterilized by a contract sterilizer since March 2017. However, no records were provided showing that the sterilization process was validated although devices processed by the sterilizer were released for distribution.
Although the firm had a validation protocol for its B-P Knee Replacement System device, there were no records to show the protocol had been followed. It was also deficient, as it did not include a physical performance qualification and did not address its applicability to other firm products.
In addition, all three of the firm’s CAPA records opened and closed since October 2016 lacked verifications that the corrective actions were successful.
Procedures were also not established to identify products that do not conform to requirements. For example, although the firm required investigation of nonconformities and their causes, eight out of 13 nonconformance reports the agency reviewed did not have investigations or justifications for why one was not needed.