FDA Orders Drug Compounding Company to Halt Operations

FDA officials said that U.S. District Judge William H. Steele has entered a consent decree of permanent injunction against compounder Medistat RX, LLC, prohibiting the company from manufacturing or distributing products until it complies with appropriate regulations.

The company, based in Foley, Alabama, had manufactured and distributed drugs amid conditions that did not meet the requirements under the Federal Food, Drug and Cosmetic (FD&C) Act. Drugs that were marketed as sterile were often contaminated with filth, which could have potentially harmed consumers. Additionally, the company also distributed unapproved drugs that were mislabeled without adequate directions for use on containers. Medistat can’t manufacturer or distribute drugs until it complies with these regulations.

The decree additionally prohibits Medistat co-owners Mark D. Acker and Timothy L. Fickling, as well as pharmacist-in-charge V. Elain Waller, from working with the company until manufacturing standards are improved.

A complaint received in the summer of 2015 sparked an FDA investigation into the company. Medistat then agreed to a voluntary recall of all its products in the United States.

FDA officials also noted an inspection of Medistat that took place in September 2014, where similar unsanitary conditions were observed. However, “despite assurances that Medistat was correcting its violations, the 2015 follow-up inspection revealed that the company had not implemented adequate corrective actions.”

Reference

Federal judge enters consent decree against Alabama compounder Medistat [news release]. FDA’s website; July 6, 2017.https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm565874.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed July 7, 2017.