US FDA issues warning to Mylan for Telangana plant

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.”