Regulatory Guidance

Mylan hit with warning letter for valsartan manufacturing

Nov 13, 2019

The FDA sent a Mylan facility in India a warning letting for its manufacturing of APIs related to the widespread recall of blood pressure medications.

According to the agency, the facility in Andhra Pradesh violated several GMP standards including a failure to have adequate written procedures for identifying and testing raw materials.

“Your procedures for receiving, identifying, testing, and handling raw materials were inadequate to ensure suitability of materials used in manufacturing, including preventing contamination and cross-contamination with nitrosamine impurities such as N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA),” the agency stated.

The agency also took issue with the facility’s cleaning practices, saying that it failed to prevent contamination or carry-over of a material that could alter the quality of the API beyond established specifications.

Mylan is one of many manufacturers that was forced to recall blood pressure medications, including valsartan, after they were found to be contaminated with several impurities. The company recalled 100 lots from this facility and was later issued a Form 483 following an FDA inspection this spring. Although Mylan is one of the biggest companies targeted by the FDA for manufacturing issues related to the recall, other companies operating in India, such as Aurobindo, have been hit with FDA actions as well.

Mylan said it is planning a response to the agency’s warning letter.

Read the full FDA letter.