FDA flags Mylan ingredients plant in ongoing fallout from global blood pressure med recalls
September 1, 2020Kyle Blankenship
Generics maker Mylan ran afoul of the FDA late last year for lax testing protocols that could have led to active pharmaceutical ingredients (API) tainted with a probable carcinogen. Learning its lesson, Mylan battened down operations at another of its Indian API plants—but the FDA still found issues.
The FDA cited Mylan for failing to adequately test recycled solvents at its Sangareddy, India Unit 7 plant imported from a contract manufacturer the agency previously flagged for nitrosamine contamination, according to a warning letter posted Tuesday.
During an inspection in February, investigators found Mylan failed to maintain cleaning records for bulk storage tanks that contained the CMO’s recycled solvents and protocols to adequately test solvents before reuse in API production.
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In a statement, Mylan said it had submitted a response to the FDA’s letter and didn’t expect an interruption in supply.
After the FDA flagged another Mylan API plant—Unit 8—in November for nitrosamine contamination, the drugmaker installed new controls to prevent a similar contamination at Unit 7.
Despite using the flagged CMO’s solvents, Mylan said “extensive testing of APIs manufactured and distributed by the site was performed for the presence of nitrosamine impurities and no evidence of cross contamination was identified.”