Sep 04, 2020

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). USFDA in their letter dated 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 the warning letter addressed to the company, FDA stated that “because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).”

The FDA inspected the drug manufacturing facility of Mylan’s Unit – 7 at Pashamylaram, in Sangareddy 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.

“Failure to correct these deviations may also result in the FDA refusing admission of articles manufactured at Mylan Laboratories Limited, Unit 7, at Plot No. 14, 99, & 100, Phase-II, IDA, Pashamylaram, Patancheru (M), Sangareddy District into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority may be subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B)”, the FDA letter further stated.

Responding to FDAs 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 a Warning Letter to Mylan’s API manufacturer, Mylan Laboratories Limited 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.

Further, the firm stated that the response to the letter will be submitted within the required time period of 15 working days.