FDA 483 - Replication Medical, Inc. - August 22, 2018

During an FDA inspection conducted from July 10 to August 22, 2018, Replication Medical, Inc. of Monmouth Junction, NJ, a U.S. manufacturer of export-only medical devices, received a Form FDA 483 detailing significant quality system deficiencies. The observations highlight critical gaps in maintaining robust control over device manufacturing and quality processes.

Key issues included the absence of an approved Device Master Record for their GelFix device, indicating a fundamental lack of documented specifications. Furthermore, the firm's Corrective and Preventive Action (CAPA) system was found to be inadequate, with activities and results not properly documented. Examples include missing water sample testing, incomplete effectiveness checks, and premature closure of CAPAs. Device History Records (DHRs) for the GelFix device frequently deviated from established specifications, showing inconsistencies in manufacturing parameters such as motor speed, pressure levels, drying times, and missing "For Export Only" labeling.

The inspection also identified a lack of control over production processes, specifically the absence of a procedure for replacing water system filters, which led to prior contamination issues. Procedures for complaint trend analysis were not routinely followed, and critical document changes, such as those for the "NeuFx Lumbar Surgical Procedure," were implemented without proper review and approval through the document change request process.

These observations indicate a failure to adhere to the quality system requirements for medical device manufacturers. Replication Medical, Inc. is required to conduct thorough internal self-audits and implement comprehensive corrective actions to address all identified violations and ensure compliance with regulatory standards. Some issues were noted as "promised to correct" or "corrected and verified" during the inspection.