US FDA issues warning to Mylan for Telangana plant

It has also recommended the company to engage a cGMP Consultant

The US FDA has issued a warning to Mylan after the inspection of its plant in Pashamylaram, Telangana. The inspection was from February 24 to 28 this year after which the drug regulator had issued a Form 483. The company had responded to it with a letter detailing the measures taken on March 20, 2020.

However, USFDA has asked for more details of the remedial measures taken and cited two deviations at the plant:

  • Failure to have adequate cleaning procedures to prevent contamination or carry-over of a material that would alter the quality of the API
  • Failure to control and monitor procedures to recover solvents to ensure that they meet appropriate standards before reuse.

It has also recommended the company to engage a cGMP Consultant. It said, “Based upon the nature of the deviations we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your API operations to assist your firm in meeting cGMP requirements.”

Mylan, in a statement, said that “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.”

“The concerns cited by the agency were based on an inspection conducted from February 24 to 28, 2020, which placed a primary focus on nitrosamine or any similar impurities. Since last fall, as have others in the industry, we have worked closely with the FDA to thoroughly investigate all potential risks associated with inquiries related to nitrosamine impurities. As noted in the Warning Letter, several months prior to the inspection, we put additional controls, corrective actions and improvements in place at Unit 7 facility to mitigate any perceived risk of product contamination with patient safety as our primary focus. Importantly, extensive testing of APIs manufactured and distributed by the site was performed for the presence of nitrosamine impurities and no evidence of cross-contamination was identified,” it added.

A response to the letter will be submitted within the required time period of 15 working days, informed the company.

APIscGMP deviationsForm 483MylansolventsUS FDAwarning
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