US FDA issues warning to Mylan for Telangana plant

The US Food and Drug Administration last week pulled up  the local unit of Netherlands-incorporated Mylan (NYSE: MYL) for violation of good manufacturing norms, including lapses in handling raw materials and issues related with cleaning of equipment, at its Andhra Pradesh-based manufacturing facility.

The inspection of its plant in Pashamylaram, Telangana, took place from February 24 to 28, after which the drug regulator issued a Form 483.

The company responded to it detailing the measures taken on March 20, 2020. However, the US FDA has asked for more details of the remedial measures taken and cited two deviations at the plant.

The regulator's letter noted 'failure to have adequate cleaning procedures to prevent contamination or carry-over of a material that would alter the quality of the API' and 'failure to control and monitor procedures to recover solvents to ensure that they meet appropriate standards before reuse'.

The US FDA has also recommended that the company engage a current Good Manufacturing Practice (cGMP) consultant.