Dakota Laboratories, Sterile Eye Drops Manufacturing Violations, South Dakota 2010

South Dakota-based Dakota Laboratories, LLC, is facing a lawsuit for violating the Food, Drug and Cosmetic Act (FDCA) in connection with the manufacture of sterile eye drops. The government filed a complaint in the U.S. District Court for South Dakota against Dakota Laboratories and its owner, Charles L. Voellinger, Sr., to block them from committing further violations.

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 Food and Drug Administration (FDA), citing a series of inspections of Dakota Laboratories' Mitchell, S.D., manufacturing facility that revealed the company's failure to establish and implement appropriate procedures for preventing microbiological contamination of drug products.

The complaint alleges that Dakota Laboratories 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.

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 government's action resulted from a series of inspections of Dakota Laboratories' manufacturing facility in 2010 and 2011, followed by a third inspection in 2012, which documented the continuing nature of Dakota Laboratories' CGMP violations.

According to the government, 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.

Source: https://www.justice.gov/archives/opa/pr/justice-department-sues-south-dakota-drug-manufacturer-improperly-producing-sterile-eye-drops