U.S. District Judge William H. Steele entered a consent decree of permanent injunction between the United States and Medistat RX of Foley, Alabama, the company’s co-owners, Mark D. Acker and Timothy L. Fickling, and quality manager and pharmacist-in-charge V. Elaine Waller. The consent decree prohibits the company from manufacturing, holding or distributing drugs until they comply with the Federal Food, Drug and Cosmetic Act (FD&C Act) and its regulations, in addition to other requirements, FDA said.
Medistat manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of cGMP requirements under the FD&C Act. Drugs prepared, packed, or held under insanitary conditions may have been contaminated with filth or otherwise harmful if given to patients. Medistat also manufactured and distributed unapproved drugs and drugs that were misbranded because their labeling did not bear adequate directions for use, which are directions under which a consumer could use a drug safely and effectively for the purposes for which the drug is intended.
The FDA most recently inspected Medistat from August to September 2015, after receiving a complaint. Following the FDA inspection, because of a lack of sterility assurance for its purportedly sterile drug products, Medistat agreed to a voluntary nationwide recall of all lots of unexpired drug products produced for sterile use and distributed since Nov. 1, 2014. Medistat also ceased sterile and non-sterile drug operations.
Medistat registered as an outsourcing facility in November 2014, but did not renew its registration the following year. The company notified the FDA it had permanently ceased operations in October 2015.