Glen­mark hit with warn­ing let­ter over pro­ce­dures, qual­i­ty con­trol is­sues at In­dia man­u­fac­tur­ing plant

The gener­ics pro­duc­er Glen­mark Phar­ma­ceu­ti­cals has been hand­ed a warn­ing let­ter by US reg­u­la­tors.

The let­ter, which was sent to the man­u­fac­tur­er on Nov. 22, not­ed is­sues from an in­spec­tion over the sum­mer at Glen­mark’s fa­cil­i­ty in the town of Colvale, In­dia, in the state of Goa.

Ac­cord­ing to the let­ter, the FDA found that Glen­mark’s in­ves­ti­ga­tion of re­ject­ed batch­es of drugs “failed to ex­tend to oth­er batch­es, dosage strengths, and drug prod­ucts.” The warn­ing let­ter al­so not­ed that the site had failed to es­tab­lish “ad­e­quate writ­ten pro­ce­dures” for pro­duc­tion and process con­trol to en­sure drugs have the cor­rect strength, qual­i­ty and pu­ri­ty.

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