RIPLEY – The U.S. District Court on Monday issued a permanent injunction against a local pharmaceutical company to prevent the distribution of adulterated drugs.
Delta Pharma, Inc. of Ripley, its President, Dr. Tommy T. Simpson, and its Vice President, Charles Michael Harrison, are prohibited from manufacturing, holding or distributing any drugs manufactured from their facility until the U.S. Food and Drug Administration (FDA) notifies them in writing that they appear to be in compliance with the ordered remedial measures.
The permanent injunction stems from a complaint filed in the U.S. District Court for the Northern District of Mississippi on June 4 at the request of the FDA, alleging, among other things, that the defendants distributed adulterated drugs in interstate commerce.
According to the complaint, Delta Pharma’s drugs may have been contaminated due to unsanitary conditions when they were prepared, packed or held. The complaint also alleged the defendants failed to comply with current good manufacturing practice requirements.
FDA conducted an inspection of Delta Pharma in February 2017. According to the complaint, FDA investigators observed and documented numerous unsanitary conditions, including the use of 50-foot-long tubing that may not have been properly sterilized.
The FDA also documented numerous deviations from current good manufacturing practice requirements for drugs, including failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. They also documented that defendants failed to thoroughly review and investigate any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications; and failed to establish an adequate quality control unit that has the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling and drug products.
“Compounding pharmacies have a responsibility to ensure that they process and label drugs in a manner that ensures the safety and quality of such drugs,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division.
“The Food, Drug, and Cosmetic Act is designed to protect the American people,” said U.S. Attorney William C. Lamar for the Northern District of Mississippi. “This civil action demonstrates our commitment to enforce laws designed to protect the health and safety of the American public.”
Delta Pharma, Inc. released this statement to the Southern Sentinel Tuesday afternoon:
“On June 1, 2018, Delta Pharma agreed with the U.S. government on the terms of a consent decree related to Delta Pharma’s compounding operations. The consent decree has been submitted to the court.
“The consent decree resolves a dispute between Delta Pharma and the U.S. Food and Drug Administration (FDA) regarding Delta Pharma’s compliance with FDA’s current good manufacturing practice (CGMP) regulations and guidance documents, and in particular, FDA’s guidance documents related to process validation and aseptic processing.
“All compounded products distributed by Delta Pharma have been fully tested by an independent laboratory for potency, sterility, and endotoxin levels, and no product has been released until final test results were received and confirmed as passing. During its most recent inspection of Delta Pharma, FDA did not take issue with the testing by our outside laboratory, and did not find that any products were released without passing results. Moreover, we have not received any complaints or reports of injuries associated with our products.”