FDA warns Mylan over valsartan manufacturing violations
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The FDA announced it issued a warning letter to Mylan Laboratories Limited over violations of current good manufacturing practice observed during an inspection of a drug manufacturing facility in India.
As Healio previously reported, Mylan Laboratories Limited is one of several companies that issued recalls due to impurities including N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), both of which have been classified as a probable human carcinogen based on laboratory results.
According to the warning letter, an FDA inspector observed a number of violations during a visit to a Mylan plant in G. Chodavaram village, Vizianagaram district, Andhra Pradesh, India, from May 27 to June 5.
Deviations from current good manufacturing practice (CGMP) included failure to have written procedures for the identification, receipt, handling and testing of raw materials and failure to clean utensils and equipment to prevent carryover or contamination of materials that would affect the quality of an active pharmaceutical ingredients beyond specifications, according to the warning letter.
The FDA recommends that Mylan connects with a consultant who is qualified to evaluate facility operations to meet CGMP requirements, although hiring a consultant does not excuse the company from its obligation to comply with CGMP.
The FDA may withhold approval of any supplements or applications that list Mylan as a manufacturer until all deviations are corrected and compliance has been confirmed. Failure to comply with this letter may result in the refusal of products manufactured at the facility from entering the U.S. by the FDA.
Mylan has 15 working days from the date of the letter, Nov. 5, to respond to the FDA.