The FDA handed MHC Medical Products a Form 483 after its January inspection revealed multiple deficiencies at its Cincinnati, Ohio facility, including poor complaint handling and management, CAPA issues and procedural shortcomings.
The agency found that the firm did not promptly look into complaints that were MDR reportable. Complaints involving needles breaking off into customers’ stomachs and another complaint regarding a faulty glucose meter were not reported as MDRs and did not have a documented review or evaluation for reportability.
In addition, the firm did not investigate other, less severe complaints, such as ones involving a needle not ejecting liquid, ripped syringe bags and missing needle tops, and the company’s complaint standard operating procedures did not define the firm’s defect codes.
The company also did not adequately define how to analyze its quality sources. Its SOP said that data would be collected, analyzed and reviewed at least quarterly, but it did not define how the analysis should be conducted. There was also no direct link between the data analysis and the firm’s CAPA system.
The firm’s supply chain manager also said the firm had no approved procedure for reviewing its contract manufacturer’s quality control reports or the documentation of the reviews, both of which are used to determine the release of products.
The company’s quality audits were missing documentation. Although an executive claimed that a quality audit was conducted in 2013 by an outside firm and in early 2017 by its current quality systems contractor, there were no records of either audit.
MHC also failed to keep records that included all consultants and contracting services used by the firm. Its current quality system consultant and the independent test laboratory used for investigations were not on its approved suppliers list.