Inservco Inc. received a Form 483 for not establishing a complaint handling procedure, failing to properly maintain device history records, and other violations.
During an inspection of the quality assembly and test services company’s Lagrange, Ohio facility in late February and early March, inspectors determined that company procedures did not state how all complaints were processed in a uniform and timely manner, how oral complaints were documented, or that complaints would be evaluated for investigation and that the evaluation would be documented.
The FDA also found that Inservco did not establish adequate procedures that defined the responsibility for review and disposal of nonconforming products. The procedures it had failed to capture all nonconformance data for evaluation, or address how nonconformance material reports should be voided or deleted.
In addition, the manufacture of about 85 devices was not properly documented in device history records. Required documents included a certificate of compliance, finished product device release, and final acceptance inspection report form, none of which were included in the device history records for these products.
Lastly, procedures for accepting incoming products and calibrating equipment were not followed, and personnel training was not properly documented. With regard to personnel training, the company did not maintain training records for any personnel related to its quality policy, quality procedures, or quality system regulations, including but not limited to complaint handling, nonconformance and CAPA management and medical device reporting. Inservco also failed to follow its resource management procedure which states that the quality policy, quality system regulations, and applicable quality procedures are formal training requirements that require formal training records to be maintained for all personnel completing them.
The FDA’s Quality System Regulation requires devicemakers to develop and maintain four files of information related to design, production and overall quality system. Order Device Documentation: A Guide to Managing Four Critical Production Files for a detailed guide that will help you understand each element and their relationships with each other, as well as guidance on how to develop the files.