A consent decree filed this month will keep a pharmaceutical company, Medistat RX, out of business due to unsanitary practices and potentially dangerous contamination, according to AL.com.
The complaint stated that Medistat manufactured, processed, and packaged drugs that could have been non-sterile at its facility in Foley, Alabama. The company distributed these potentially non-sterile drugs to patients, surgery centers, and doctors’ offices in California, New York, Texas, and other cities throughout the country.
The complaint was filed in May by attorneys representing the Consumer Protection Branch of the Department of Justice, as well the U.S. Department of Health and Human Services. Named in the complaint were CEO and co-owner of Medistat Mark D. Acker, production manager and co-owner Timothy L. Fickling, and quality manager and pharmacist-in-charge V. Elaine Waller.
The consent decree was agreed to “without contest” by the defendants, according to AL.com.
Prior to this decree, Medistat was found to be in violation of the FDA in numerous aspects, including lapses in procedure that created the potential for sterile drugs to be contaminated and cause serious complications for patients. The company also failed to investigate such problems and take corrective action.
Following these 2014 and 2015 inspections, Medistat announced a voluntary product recall in September 2015 and stopped both sterile and non-sterile operations. Medistat was also dissolved as a legal entity in 2016.
The consent decree filed this month aimed to prevent Medistat from committing any further violations. Specifically, government representatives said that they sought an injunction that would “permanently restrain and enjoin Defendants…from manufacturing, processing, packing, labeling, holding, or distributing any article or drug, unless and until Defendants bring their…operations into compliance with the Act and its implementing regulations to the satisfaction of FDA,” as reported by AL.com.
After five years, Medistat can petition the court for relief from the terms of the decree. The document includes an extensive list of requirements Medistat would have to meet in order to be allowed to presume any manufacturing or similar activity.
Prosecutors say they will not oppose Medistat after the five years have passed if they have been in continuous compliance.
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