FDA Cites Oxford Performance Materials for Procedural Issues

The FDA cited Oxford Performance Materials for five issues from environmental control procedures to equipment maintenance.

The agency issued a Form 483 to Oxford’s South Windsor, Conn., facility, following a March/April inspection. According to investigators, the facility did not conduct cleaning validation for the compound used to clean its HTR-PEKK cranial implant to ensure the compound’s effectiveness. Investigators also observed a bag of the material used to finish the implants that was ripped and repaired with packing tape, and receiving records indicated acceptance of material without a record of inspection.

The facility also failed to established acceptance criteria for monitoring viable and non-viable samples, and its process validation for pre-vacuum steam sterilization for cranial implants did not include the review and approval of the report.