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Mylan gets FDA warning letter for Telangana plant
USFDA investigators found lapses in the plant as there were no adequate cleaning procedures to prevent contamination
Drug maker says no impact, will respond within 15 days
Hyderabad: The US Food and Drug Administration (US FDA) has served a warning letter to pharma firm Mylan Laboratories Ltd's plant in Telangana for significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API).
The US drug regulator in a letter on September 1, 2020, told the drugmaker that the FDA investigators found lapses in the plant as there were no adequate cleaning procedures to prevent contamination or carry-over of a material that would alter the quality of the API. Representatives from the US FDA carried out inspection of the drug manufacturing facility of Mylan's Unit 7 at Pashamylaram, in Sangareddy District, during February 24-28, 2020.
The FDA said in the letter that "in addition to your lack of cleaning records, your cleaning validation and verification programme for non- dedicated manufacturing and storage equipment are inadequate. Until you correct all deviations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new drug applications or supplements listing your firm as a drug manufacturer."
However, Mylan shrugged it off, while responding to FDA's warning Letter. Mylan in a statement said, "it doesn't anticipate any interruption in manufacturing and distribution at the site.
"The US Food and Drug Administration issued a Warning Letter to Mylan's API manufacturer, Mylan Laboratories Ltd Unit 7, in which no interruption in manufacturing and distribution is anticipated at the site, no significant commercial impact is expected and no significant launches are planned for Unit 7 in 2020," Mylan said. Mylan further said the response to the letter will be submitted within the required time period of 15 working days.
Mylan's plant at Pashamylaram makes active ingredients for drugs. USFDA found that it hadn't taken the proper precautions to ensure solvents it used didn't contain impurities, including failing to adequately test the raw materials. The FDA has recommended Mylan Chief Executive Officer to hire a consultant to help the generic drugmaker improve its manufacturing practices.
Mylan further stated that extensive testing of the active pharmaceutical ingredients (APIs) has been performed for the presence of nitrosamine impurities and no evidence of cross contamination was identified. "We take very seriously our continued and comprehensive oversight of Mylan's entire manufacturing network," said Mylan.
