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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

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.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

Vipin Garg, Altimmune CEO

Al­tim­mune’s shares halved af­ter in­ter­im look at PhII weight loss drug da­ta

Altimmune’s attempt to catch up to Novo Nordisk and Eli Lilly’s GLP-1 drugs hit an investor snag Tuesday after the biotech shared interim Phase II weight loss data.

The Maryland biotech’s pemvidutide is a GLP-1/glucagon dual receptor agonist meant to activate GLP-1 receptors to squash appetite and glucagon to ramp up energy use. The 2.4 mg dose showed a placebo-adjusted weight loss of 9.7% at week 24 of 48, which Jefferies analysts said would be comparable to Novo Nordisk’s semaglutide (Wegovy) and Eli Lilly’s tirzepatide (Mounjaro).

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

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.

Harpreet Singh, Immatics CEO

Im­mat­ics an­nounces mul­ti­ple pipeline changes with lat­est fi­nan­cial re­sults

The T-cell biotech Immatics is looking to make some changes to its pipeline.

Immatics released its 2022 financial results on Tuesday and announced that it’s planning to discontinue its program for IMA201, an experimental cell therapy for solid tumors that express the antigens known as MAGE4/8. It plans to shift focus to IMA401, a TCR bispecific which goes after the same target.

The German-based biotech said it will treat the remaining patients enrolled in the program before the discontinuation. No other reasons were given for the discontinuation. Endpoints News reached out to Immatics for more details but did not receive a response by press time.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.