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FDA issued a warning letter to the company for quality control violations.
Edit: Updated Sept. 16, 2016
FDA issued a warning letter on August 15, 2016 to Frontida BioPharm for quality violations observed during an inspection performed from June 15–July 17, 2015 at the company’s Philadelphia facility (formerly known as Mutual Pharmaceutical Company). The company was cited for failing to establish an adequate quality control unit and for failing to provide investigators with proper information.
Specifically, FDA investigators observed that the company’s quality unit released potentially contaminated lots of clonidine HCl tablets after being informed that the supplier of the API had recalled the API. FDA stated in the letter that the company’s vice-president denied knowledge of the recall; however, email collected during the investigation showed the VP had been notified in July 2014. According to FDA, the company removed the VP from his position during the inspection.
The agency also found that the company had inadequately investigated stability failures for an unknown impurity. A lack of ensuring accurate records consistent with standard operating procedures was also cited in the warning letter.
During the inspection, the company failed to provide FDA investigators with information on investigations, corrective actions, and preventive actions. “When an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs may be adulterated under section 501(j) of the FD&C Act,” FDA stated in the letter.
FDA recommended the company provide a plan to ensure an adequate quality control unit, describe to the agency improvements to the company’s supplier qualification and auditing program, provide results of an audit of the HCl API supplier, and conduct a retrospective evaluation of drug products “within expiry to ensure they do not exceed specifications for any known or unknown impurities. Provide the results of this evaluation and indicate the steps you have taken to investigate any out-of-specification results you identify as part of this retrospective evaluation.”
In an unpublished statement provided to Pharmaceutical Technology dated Sept. 2, 2016, Frontida stated, "Mutual [a subsidiary of Sun Pharma] divested the facility and certain other assets to Frontida BioPharma Inc. on June 3, 2016, with full transparency to Frontida surrounding the FDA observations in the Form 483 citation issued following the inspection of the facility. As part of the divestment process, Sun Pharma committed, post-closing, to support Frontida in the completion of the remediation of the issues raised in the Form 483 citation, which are further raised in the warning letter that FDA issued on August 15, 2016. Frontida continues to manufacture products for Mutual at this facility, and is committed to manufacturing products that meet high standards of quality and safety."