The US Food and Drug Administration has issued a Warning Letter to Mylan Laboratories Limited’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 told the drug-maker 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.
“In addition to your lack of cleaning records, your cleaning validation and verification programme for non-dedicated manufacturing and storage equipment are inadequate,” the FDA said. The FDA inspected the drug manufacturing facility of Mylan’s Unit 7 at Pashamylaram, inSangareddy District, from February 24 to 28, 2020.
“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,” the FDA letter said. Responding to FDA’s warning Letter, Mylan in a statement said it does not anticipate any interruption in manufacturing and distribution at the site.
“The US Food and Drug Administration (FDA) issued aWarning Letter to Mylan’s API manufacturer, Mylan LaboratoriesLimited 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 on September 1.
Mylan further said the response to the letter will be submitted within the required time period of 15 working days.
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