Un­san­i­tary con­di­tions and oth­er QC is­sues raised by FDA in a warn­ing to con­tract pack­ager

A warn­ing let­ter from the FDA to a con­tract phar­ma pack­ager is rais­ing con­cerns over qual­i­ty and clean­ing is­sues at its fa­cil­i­ty.

Lega­cy Phar­ma­ceu­ti­cal Pack­ag­ing, based in Earth City, MO, a sub­urb of St. Louis, has re­ceived a warn­ing let­ter from the FDA stem­ming from an in­spec­tion from April.

The com­pa­ny was not­ed for hav­ing prod­uct mix-ups, with equip­ment de­sign flaws and im­prop­er clean­ing. And while the com­pa­ny stat­ed that it would in­ves­ti­gate the mix-ups, this re­sponse is not sat­is­fac­to­ry for the FDA, with the agency telling the com­pa­ny:

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