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FDA announced the recall, citing deficiencies in Medistat’s aseptic processing areas and in its environmental monitoring procedures.
Medistat voluntarily ceased sterile compounding operations on Sept. 1, 2015 after FDA reported sterility assurance concerns with the outsourcing facility. The agency reported that it had received reports of several adverse events that were potentially associated with drug products made by Medistat.
An inspection by FDA and state investigators in September 2014 revealed that the Foley, Alabama plant did not meet expectations for the production of sterile products. Namely, Medistat did not provide FDA with sufficient evidence of proper air quality precautions-such as metrics on air exchange rates, particle counts, and pressure differentials-in classified rooms where sterile compounding occurred. Laminar flow hoods were not certified, FDA argued, and Medistat failed to perform personnel and environmental monitoring on a daily basis. In addition, FDA regulators said Medistat did not validate its sterilization process for the prevention of microbial contaminants, nor did its media fills accurately simulate actual product quantities.
FDA also wrote in a report that drugs that failed to meet specifications were not rejected, and as a result, two lots of failed progesterone capsules that failed potency tests were still distributed. Other problems outlined by the agency dealt with failure to perform endotoxin testing or growth promotion testing of the agars and media used for sterility analysis, and failure to validate its claim that all of its drugs are free of pyrogens. Operators were charged with wearing facemasks that did not meet sterility requirements during compounding, and FDA pointed out that Medistat did not calibrate its incubator thermometers.
Medistat voluntarily registered its specialized pharmacy as the first FDA 503B outsourcing facility in Alabama in 2014, according to the company. Registering as an outsourcing facility means that the pharmacy has to comply with FDA's current good manufacturing practice requirements and will be subject to FDA inspection on a “risk-based” schedule. After FDA determined Medistat did not properly address its sterility concerns-issued via a Form FDA 483 in September 2014-the company agreed to recall all of its products that were distributed between Nov. 1, 2014 and Sept. 3, 2015. Following the FDA announcement, Medistat will likely need to change its website’s Q&A section, which states that the company has never had any product recalls related to quality issues with its products.