Mylan receives US FDA warning for lack of quality control at Telangana unit

Pharmaceutical firm Mylan N.V. received a warning from the US Food and Drug Administration for failure to avoid contamination of active pharmaceutical ingredients (API) at its plant in Telangana.

“Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated...,” the US regulator said in its warning letter published on its website on Monday. The warning letter, seen by Mint, was issued to the company on 20 August.

The US FDA had inspected the plant at Pashamylaram in Telangana from February 24 to 28 this year. The regulator observed that the facility did not have adequate cleaning procedures to prevent contamination or carry-over of a material into the API batches and also failed to meet appropriate standards while reusing solvents.

The regulator was observed similar violations at its Vizianagaram unit in Andhra Pradesh after an inspection last year, following which the Andhra plant had also received a warning letter in November.

“These repeated failures at multiple sites manufacturing API demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” the US FDA said.

After the inspection at the Pashamylaram plant in February, the regulator had issued a Form 483 listing the violations, following which the company had provided a response on 20 March detailing some of the procedures. However, the US FDA has asked for more details on its remediation measures, and also suggested that the company hire an external consultant to evaluate the operations to assist it in meeting current norms.

In its statement, Mylan said that no major commercial impact is expected and no significant launches are planned for Unit 7 in 2020. Mylan said it will respond to the letter within the required time of 15 working days.

“Mylan is committed to maintaining the highest quality manufacturing standards at all of its facilities around the world,” the company said.