FDA in­spec­tion un­cov­ers cher­ry-col­ored an­tibi­ot­ic residue on equip­ment at Teva's New Jer­sey site

An FDA in­spec­tion re­port on Te­va’s man­u­fac­tur­ing site in New Jer­sey has re­vealed is­sues with both equip­ment clean­ing and qual­i­ty.

The three-page re­port, which was ob­tained by End­points News via a FOIA re­quest from the FDA, showed sev­er­al ob­ser­va­tions from its in­spec­tion, which took place be­tween Nov. 1 and Nov. 10 of last year, at Te­va’s site in Fair­field, NJ.

In­spec­tors not­ed a buildup of “un­known residue” with­in two pro­duc­tion rooms that had been doc­u­ment­ed as cleaned. Specif­i­cal­ly, a pink- or red-col­ored residue was found on equip­ment in the mix­ing room that had most re­cent­ly been used to man­u­fac­ture Ce­fadrox­il tablets. Ce­fadrox­il, which is used to treat bac­te­r­i­al in­fec­tions in var­i­ous parts of the body, does not use any dyes or fla­vor­ings.

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