U.S. District Judge William H. Steele entered a consent decree of permanent injunction yesterday between the United States and Medistat RX LLC 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 Medistat, its owners and pharmacist-in-charge 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.
Medistat manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice 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.
“This consent decree reflects the FDA’s continued commitment to taking appropriate action against companies that fail to safely produce sterile drugs,” said Melinda Plaisier, the FDA associate commissioner for regulatory affairs.
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.
Previously, the FDA inspected Medistat in September 2014 and observed similar poor conditions and practices for sterile drug production. Despite assurances that Medistat was correcting its violations, the 2015 follow-up inspection revealed that the company had not implemented adequate corrective actions.
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.
The complaint was filed by the U.S. Department of Justice on behalf of the FDA.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.