Devicemaker Kelyniam Global drew a warning letter from the FDA after failing to adequately address numerous GMP issues observed in a May inspection of its Canton, Connecticut facility, including the manufacturing of unapproved implants.
In its response to a Form 483 report issued after the inspection, the firm failed to provide documentation to support its promises to correct the problems, and just said it would create a CAPA for each nonconformance and perform relevant evaluations.
Problems identified in the inspection included a failure to validate several device design changes and to initiate complaint investigations. Other deficiencies were related to device master records, process validation, and procedures for accepting new materials.
The facility lacked testing documentation for cranial implants and maxillofacial implants, had been using test reports for implant cleaning validation that had not been approved, and it lacked requirements to ensure that new material meets specifications.
Management had not reviewed the firm’s quality system since Jan. 11, 2016, the FDA investigator found. The inspection also revealed that the firm lacked CAPA procedures. One ineffective corrective action involved failing to verify that employees were being trained on the most current device revisions.