The government filed suit in the U.S. District Court for South Dakota against Dakota Laboratories LLC and its owner to block them from violating the Food, Drug and Cosmetic Act (FDCA) in connection with their alleged violations of Current Good Manufacturing Practices (CGMP). The alleged violations concerned problems with the manufacture of eye drops that may have caused the products to be non-sterile. The Justice Department filed the suit on behalf of the FDA.
“Consumers must be able to trust that drugs presented as sterile are, in fact, sterile,” said Stuart F. Delery, Assistant Attorney General for the Justice Department’s Civil Division. “We cannot take the chance that a manufacturer’s failure to establish proper controls for sterile drug production could result in products becoming contaminated, placing consumers at risk of infection and potentially serious injury.”
In conjunction with the filing of the complaint, Dakota Laboratories agreed to settle the litigation and be bound by a Consent Decree of Permanent Injunction that prohibits them from committing violations of the FDCA. The consent decree also acknowledges that Dakota Laboratories is no longer in operation, and requires that if they wish to resume manufacturing drug products in the future, the FDA first must determine that Dakota Laboratories’ manufacturing practices have come into compliance with the law. The proposed consent decree, along with the complaint, has been filed with the court and is awaiting judicial approval.
The government’s action resulted from a series of inspections of Dakota Laboratories’ Mitchell, S. D., manufacturing facility, which revealed that Dakota Laboratories failed to establish and implement appropriate procedures for preventing microbiological contamination of drug products. They allegedly lacked sufficient control over the environment in their sterile processing area to prevent products from becoming contaminated and failed to establish and implement appropriate laboratory procedures for determining whether batches of eye drops conformed to their safety specifications.
Compliance with CGMP requirements ensures that drugs meet the safety requirements of the law and have the identity, strength, quality and purity that the drugs purport to possess. FDA regulations, which establish the minimum CGMP requirements applicable to human drugs, require manufacturers to control all aspects of the processes and procedures by which drugs are manufactured to prevent the production of unsafe and ineffective products.
After the inspections of Dakota Laboratories in 2010 and 2011, the FDA warned them that their conduct violated the FDCA. In 2012, a third FDA inspection documented the continuing nature of Dakota Laboratories’ CGMP violations. Consequently, the government filed its complaint and settled with Dakota Laboratories. A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.
See the DOJ Announcement
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication