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Mylan received a warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.
An FDA warning letter, dated Aug. 6, 2015, was issued to Mylan regarding cGMP violations at three facilities in India found during inspections in 2014 and 2015. The Mylan Laboratories Limited, Onco Therapies Limited (OTL) facility was inspected from Feb. 6–13, 2015; the Agila Specialties Pvt Ltd, Specialty Formulation Facility (SFF) facility, was inspected Sept. 23–Oct. 3, 2014; and the Agila Specialties Pvt Ltd, Sterile Product Division (SPD), was inspected Aug. 1–8, 2014.
Mylan responded in a Aug. 18, 2015 press release that the company has made progress in addressing quality problems. "Since Mylan acquired the Agila injectables businesses in December 2013 to create a leading global injectables platform, we have been taking extensive action to integrate the Agila business into Mylan's One Quality Standard and to ensure our leading position as a high quality, reliable source of injectables for the long term. As part of this ongoing process, we have a deep and unwavering commitment to quality everywhere we operate. We have been and will continue to work diligently to address all of FDA's observations and have made important progress," said Mylan CEO Heather Bresch in the release.
FDA’s letter said, regarding the OTL and SFF sites, “Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).” During the FDA inspection of the OTL site, investigators found non-integral gloves (e.g., with tears and pin holes), a lack of follow-up action for environmental control issues, deficiencies in operators’ practices that indicate a deficient manufacturing personnel monitoring program, and other problems. FDA noted in the letter that, “In response to our inspection, you followed a Product Quality Assessment (PQA) protocol and found visible foreign particulate matter within your examined lots,” which was followed by voluntary recalls of seven lots in March and April 2015 and an additional eight lots in June. FDA called on the company to “send a progress report on your search for the root cause of this particulate contamination problem.”
At the SFF site, FDA found inadequate process simulation (media fill) studies, failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas, and failure to “exercise appropriate controls over computer or related systems to assure that only authorized personnel can change master production and control records, or other records.”
At the SPD site, FDA noted inadequate investigations of failure to meet specifications and of complaints, as well as failure to establish adequate environmental monitoring and failure to follow procedures for preventing microbiological contamination.
FDA acknowledged that the Agila facilities were acquired by Mylan recently, but pointed to a September 2013 warning letter and said, “Even without this Warning Letter, your corporate quality system should have detected and corrected the forgoing violations without FDA intervention.”