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.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.