Mylan Receives FDA Warning Letter for Indian API Plant
By

Mylan has received a Warning Letter from the US Food and Drug Administration (FDA) related to data-integrity issues for finished pharmaceuticals at its drug manufacturing facility in Maharashtra, India. The FDA noted the violations during its inspection of the facility from September 5 to 14, 2016. The agency has reviewed Mylan’s response on October 5, 2016 and has acknowledged receipt of the company’s subsequent correspondence.

During its inspection, the FDA observed that Mylan failed to thoroughly investigate unexplained discrepancy or failure of a batch or any of its components to meet specifications and failed to establish adequate quality control to review production records for errors and to thoroughly investigate any errors that did occur. From January 1 to June 30, 2016, the agency cited that Mylan invalidated 101 out of 139, or approximately 72% of, initial out-of-specification (OOS) assay results without sufficient investigation to determine the root cause of the initial failure. In addition, the report cited that the company’s quality unit failed to monitor and investigate error signals generated by the computerized systems used for high-performance liquid chromatography and gas chromatography, which indicated the loss or deletion of original cGMP analytical data. The report specified that the quality unit did not comprehensively address the error signals or determine the scope or impact of lost or deleted data until after the problems were reviewed during the FDA’s inspection.

In response to the Warning Letter, the FDA requires Mylan to conduct and provide results of a trend analysis of all its OOS results that includes both confirmed root causes and initial OOS results and revise and provide updated laboratory investigation report procedure. In addition, in its response, Mylan is to provide validation of laboratory instrument error codes; identify the specific codes that may impact product quality and the reliability of cGMP data; and provide procedures to demonstrate how the quality unit will review, investigate, and respond to the specific codes.

This latest Warning Letter comes after the FDA issued an earlier Warning Letter to Mylan in August 2015 for three sterile manufacturing facilities in Bangalore, India that Mylan gained as part of its $1.75-billion acquisition of Agila Specialties in 2013. The FDA conducted inspections at Mylan Laboratories Limited OTL in Bangalore from February 6 to 13, 2015; Agila Specialties Private Ltd., Specialty Formulation Facility in Bangalore from September 23 to October 3, 2014; and at Agila Specialties Private Ltd., Sterile Product Division in Bangalore from August 1 to 8, 2014.

Among the violations cited by the FDA at these three Bangalore facilities were quality control violations, which included a failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile; failure to follow appropriate environmental monitoring protocol for sterility assurance; and failure to establish laboratory controls that included scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.

Source: US Food and Drug Administration 

Leave a Reply

Your email address will not be published.