- The Food and Drug Administration this month warned Mylan over manufacturing shortcomings the regulator found at an Indian plant producing the blood pressure medicine valsartan.
- The FDA's warning letter stemmed from an inspection that ran from May 27 to June 5, about six months after Mylan decided to recall all its batches of valsartan due to contamination with the carcinogen N-Nitrosodiethylamine, or NDEA.
- Mylan's June 26 response to the inspection report was inadequate, the FDA said. In its letter, the agency requested a new response within working 15 days and outlined steps that should be taken, including retaining a consultant to help meet manufacturing requirements.
After a flood of recalls, the FDA has been working to find and address the root causes of impurities seen across the class of drugs known as sartans. As the regulator's work unfolds, it's formalizing findings of fault in warning letters sent to manufacturers.
Last month, the agency sent a warning letter to Torrent Pharmaceuticals citing problems at an Indian plant producing losartan. The FDA also warned a China-based valsartan manufacturer about its practices.
Regulators said the Mylan plant doesn't have adequate procedures for identification, testing and handling of raw materials to ward off contamination with impurities such as NDEA.
The letter largely focused on the use of recovered solvents that Mylan blamed for contamination. The plant failed to document which manufacturer's solvent was stored in a particular tank and didn't adequately investigate the potential for cross-contamination, the FDA said in its Nov. 5 letter.
Inspectors also documented a failure to properly clean equipment and utensils, the agency said. In one case, inspectors used lint-free cloths to wipe interior surfaces of chutes that were supposed to be clean. They found stains that later tests determined were residual valsartan, the FDA said.
The warning letter brings one more headache for Mylan, which has been struggling with sliding sales amid intense competition in the generic market. The company got a potential lifeline in July, when it entered an agreement to merge with Pfizer's Upjohn unit.
Mylan and Pfizer announced this week the name of the newly formed company will be Viatris. They expect the deal to close in the middle of next year.