Multiple Denison Pharmaceuticals Violations

A 1/5-2/9 FDA inspection at the Denison Pharmaceuticals drug manufacturing facility in Lincoln, RI, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs, and other violations. A 7/26 Warning Letter says specific CGMP violations were:

• failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
• failing to conduct at least one test to verify the identity of each component of a drug product; and
• failing to establish the accuracy, sensitivity, specificity, and reproducibility of its test methods.

The letter also says the firm is manufacturing three unapproved new drugs that are labeled as homeopathic drugs. It notes that homeopathic products are subject to the same statutory requirements as other drugs.

FDA says it recommends that Denison remove any batches of drug products currently in distribution from the U.S. market that were manufactured between 4/2020 and 12/2020, when the company used a non-food grade lubricant for the mixing vessel.

The letter reminds Denison that it is responsible for the quality of drugs it produces as a contract facility regardless of agreements in place with product owners.

“Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP,” the letter says. “In addition to the lack of effective production operations oversight to ensure reliable facilities and equipment, we found that your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements.”

FDA recommends that Denison engage a qualified consultant to perform a comprehensive six-system audit of the company’s entire operation for CGMP compliance and evaluate the completion and efficacy of its corrective and preventive actions before it pursues resolution of its compliance status with the agency.

Denison was told to correct any violations promptly and to respond with a list of specific steps it has taken to address violations and prevent their recurrence, with a schedule for completing the corrections.