In­tas Phar­ma­ceu­ti­cals un­der FDA scruti­ny over 'cas­cade of fail­ure' in over­sight of GMP doc­u­ments

In­tas Phar­ma­ceu­ti­cals is in the FDA’s hot seat af­ter in­spec­tors not­ed a va­ri­ety of is­sues on a re­cent plant vis­it, in­clud­ing shred­ded records that were al­leged­ly found in trash ar­eas, a near­by truck, and hid­den un­der a stair­case.

The Ahmed­abad, In­dia-based man­u­fac­tur­er re­ceived a Form 483 — a doc­u­ment giv­en out when in­spec­tors ob­serve “ob­jec­tion­able” con­di­tions — fol­low­ing a site in­spec­tion con­duct­ed be­tween late No­vem­ber and ear­ly De­cem­ber of last year. In­ves­ti­ga­tors not­ed a slew of po­ten­tial is­sues in the 36-page form, in­clud­ing in­com­plete lab records and a “cas­cade of fail­ure” in the qual­i­ty unit’s over­sight of Good Man­u­fac­tur­ing Prac­tices (GMP) doc­u­ments.

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