Texas drug man­u­fac­tur­er smacked with FDA warn­ing let­ter over mul­ti­ple vi­o­la­tions

A Texas drug man­u­fac­tur­ing fa­cil­i­ty has drawn the FDA’s ire over miss­ing records, in­ad­e­quate process­es and faulty con­trols on a laun­dry list of in­frac­tions out­lined in an agency warn­ing let­ter.

Fort Worth-based Monarch PCM, which makes phar­ma­ceu­ti­cal liq­uids, tablets, creams and lo­tions among oth­er prod­ucts, was in­spect­ed by the FDA from June through Au­gust last year. The new FDA warn­ing let­ter dat­ed June 10, 2022, list­ed the com­pa­ny’s meth­ods, fa­cil­i­ties and con­trols for a range of man­u­fac­tur­ing and pro­cess­ing is­sues that did not con­form to cur­rent good man­u­fac­tur­ing prac­tices (CGMP).

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