The FDA has sent a Warning Letter to Mylan N.V. (MYL -1.1%) concerning “significant deviations” from good manufacturing practice for active pharmaceutical ingredients (API) at its Unit 8 facility in Vizianagaram, Andhra Pradesh, India.
An on-site inspection from May 27 – June 5 found the following deficiencies:
Failure to adequately maintain written procedures for the receipt, identification, testing and handling of raw materials (cited NDMA and NDEA contamination of valsartan).
Failure to clean equipment and utensils to prevent contamination or carry-over of a material that could affect the quality of the API.
The company has 15 working days to submit a response to the letter including its plan to promptly address the deviations. Failure to do so could put future FDA approvals at risk.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.