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).

The warn­ing let­ter con­tained sev­er­al vi­o­la­tions that par­tic­u­lar­ly con­cerned the FDA, start­ing with the com­pa­ny fail­ing to in­ves­ti­gate any un­ex­plained dis­crep­an­cies or batch fail­ures.

The FDA main­tains that the com­pa­ny failed to ad­e­quate­ly in­ves­ti­gate out of spec­i­fi­ca­tion (OOS) re­sults for both drug com­po­nents and fin­ished drug prod­ucts, in­val­i­dat­ing mi­cro­bial re­sults due to lim­it­ed and in­ad­e­quate in­ves­ti­ga­tions. The com­pa­ny al­so failed to thor­ough­ly in­ves­ti­gate mul­ti­ple out-of-lim­it mi­cro­bial re­sults in both old and new wa­ter sys­tems. Ad­di­tion­al­ly, the com­pa­ny did not ad­dress po­ten­tial root caus­es as nu­mer­ous aque­ous-based drug prod­ucts were man­u­fac­tured and re­leased dur­ing a pe­ri­od from 2019 to 2021.

The com­pa­ny failed to ex­tend mi­cro­bial con­t­a­m­i­na­tion in­ves­ti­ga­tions to oth­er po­ten­tial­ly im­pact­ed drug prod­ucts, the let­ter adds.

An­oth­er ma­jor is­sue? Monarch failed to use ap­pro­pri­ate­ly de­signed and sized equip­ment in the man­u­fac­ture or pro­cess­ing of drug prod­ucts. Specif­i­cal­ly, its wa­ter sys­tems and man­u­fac­tur­ing equip­ment were not de­signed, cleaned and main­tained ap­pro­pri­ate­ly with the FDA not­ing sev­er­al in­frac­tions spe­cif­ic to the wa­ter is­sues.

The com­pa­ny re­spond­ed by in­cor­po­rat­ing a new wa­ter sys­tem per­for­mance qual­i­fi­ca­tion pro­to­col and de­vel­op­ing a plan to ex­e­cute the new pro­to­col, but the re­spons­es were not suf­fi­cient for the FDA.

The com­pa­ny’s qual­i­ty con­trol unit al­so failed to re­spon­si­bly en­sure drug prod­ucts man­u­fac­tured were fol­low­ing CGMP stan­dards, the FDA charges. The FDA in­spec­tors, for in­stance, found test­ing for Burk­holde­ria cepa­cia com­plex (BCC or B. cepa­cia) was not per­formed as re­quired per es­tab­lished spec­i­fi­ca­tions, batch pro­duc­tion records were not be­ing es­tab­lished and CGMP records were miss­ing pri­or to the in­ves­ti­ga­tion.

The com­pa­ny al­so failed to es­tab­lish and fol­low a prop­er­ly writ­ten test­ing pro­gram de­signed to as­sess the sta­bil­i­ty char­ac­ter­is­tics of drug prod­ucts.

The FDA let­ter says a fail­ure to ad­dress the mat­ters can re­sult in reg­u­la­to­ry or le­gal ac­tion in­clud­ing seizures or an in­junc­tion. Un­re­solved vi­o­la­tions may al­so pre­vent oth­er fed­er­al agen­cies from award­ing con­tracts. The FDA can al­so with­hold the is­suance of ex­port cer­tifi­cates or the ap­proval of new ap­pli­ca­tions.

The com­pa­ny was giv­en 15 days from the June 10th is­sue date to re­spond to the let­ter.

Monarch did not re­spond to an in­quiry from End­points News by press time.

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