In­gre­di­ent man­u­fac­tur­er Cen­taur gets FDA warn­ing over records, sub­stan­dard clean­ing

Ac­tive phar­ma­ceu­ti­cal in­gre­di­ent mak­er Cen­taur Phar­ma­ceu­ti­cals re­ceived a warn­ing let­ter from the FDA in ear­ly June over sev­er­al is­sues at its man­u­fac­tur­ing site in the city of Thane, In­dia, near Mum­bai.

The agency in­spect­ed the site in No­vem­ber of last year. The FDA found that the site’s qual­i­ty unit didn’t have the prop­er con­trol over elec­tron­ic and pa­per records. Specif­i­cal­ly, the FDA found dif­fer­ent doc­u­ments that were pre-print­ed and blank in lab­o­ra­to­ry draw­ers and cab­i­nets that had un­re­strict­ed ac­cess. Doc­u­ments were al­so shred­ded with­out re­view.

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