FDA sends warn­ing let­ter to My­lan over 'i­nad­e­quate' man­u­fac­tur­ing process­es at In­dia plant

My­lan has once again run afoul of the FDA over its lack of up­keep at man­u­fac­tur­ing plants.

For the sec­ond time in the last 12 months, the agency has sent a warn­ing let­ter to the gener­ic drug­mak­er call­ing out its fail­ure to main­tain in­dus­try-stan­dard clean­ing pro­ce­dures that pre­vent con­t­a­m­i­na­tion. In the let­ter, sent on Aug. 20 and pub­lished Tues­day, reg­u­la­tors al­so al­lege My­lan $MYL did not test in­com­ing API for im­pu­ri­ties, have mech­a­nisms in place to de­tect such im­pu­ri­ties from en­ter­ing prod­ucts, or keep clean­ing records for bulk stor­age tanks.

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