Mylan plant knocked for sloppy manufacturing controls in tainted valsartan fiasco

FDA Building 2
The FDA knocked Mylan for inadequate manufacturing controls at an Indian plant that found tainted lots of a valsartan API. (FDA)

After the FDA issued a global recall last year of "sartan"-based drugs contaminated with a possible carcinogen, there's been plenty of blame to pass around. The most recent recipient of regulators' ire is Mylan, which was knocked with a warning letter criticizing procedures at an Indian plant.

Mylan failed to present written procedures to control the testing and handling of valsartan API at Unit 8 of its Andhra Pradesh, India, plant during an inspection in May, the FDA said in its Nov. 5 letter.

Mylan's process were "inadequate" to prevent "contamination and cross-contamination with nitrosamine impurities," including N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), the FDA said.


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The FDA inspection in May followed Mylan's recall of more than 100 lots from the facility late last year after "low levels of NDMA" were found in some of its API, the letter said. Instead of following up on an FDA Form 483 in June with an adequate plan, Mylan "did not provide sufficient detail or evidence of corrective actions," the FDA alleged. 

Mylan said in a statement that it planned to respond to the FDA's letter and did not anticipate a halt in manufacturing or commercial launches.

"Mylan will be providing a thorough response to the Agency which will detail existing controls in place at the facility to mitigate any perceived risk of product contamination and provide additional enhancements as requested," the company said. "No significant commercial impact is expected and no significant launches are planned for Unit 8 in 2020."

RELATED: FDA cites solvent recovery firm as a player in the valsartan mess

Mylan is the most high-profile drugmaker blasted by the FDA for failing to control nitrosamine contamination in its API, but it's not the first.

In July, Aurobindo received a warning letter for its Srikakulam plant after an inspection in February just weeks after Aurobindo recalled 80 lots of valsartan because of the detection of NDEA. The highly redacted letter mentioned Aurobindo’s use of solvents to produce drugs that exceeded the FDA’s acceptable levels for the impurities.

In August, the administration issued another warning letter to an Indian solvent recovery firm whose products may have contributed to some of the tainted drugs. The letter to Lantech Pharmaceuticals said its processing methods left open the chance for cross-contamination of solvents.

Mylan tied its own contamination back to tainted solvents as well, telling the FDA that contract manufacturers had sent contaminated batches. The FDA still knocked Mylan for not doing enough to adequately track individual batches.

"Multiple contract manufacturers supplied solvents that were contaminated with nitrosamines, but your firm lacked documentation of which tanks were used to store these solvents," the FDA said. "Although you acknowledged that there was no record of usage for each of the recovered solvent tanks, your response did not provide sufficient information on attempts to retrospectively reconcile the number, identification, and usage of the tanks."

NDMA and NDEA were not only at the root of the FDA global recall of sartan blood pressure meds but have also led to widespread recalls of heart burn med Zantac after small amounts of NDMA were found in certain lots of the drug.

After a group of drugmakers and retailers opted to pull generic and branded Zantac from shelves, the FDA––in a move likely meant to shore up consumer confidence––said the levels of NDMA found in tested lots were no higher than that found in "grilled or smoked meats."