Emer­gent BioSo­lu­tions is fac­ing a fresh set of man­u­fac­tur­ing trou­bles as the FDA is­sued a warn­ing to the com­pa­ny re­gard­ing its Bal­ti­more site.

Emer­gent re­vealed in an SEC fil­ing on Fri­day that the US reg­u­la­tor is­sued a warn­ing let­ter on Aug. 10, flag­ging two ar­eas of con­cern at the com­pa­ny’s Cam­den man­u­fac­tur­ing fa­cil­i­ty in Bal­ti­more.

The FDA let­ter point­ed to de­fi­cien­cies in the Emer­gent plant’s sys­tems for clean­ing and main­te­nance of equip­ment to pre­vent con­t­a­m­i­na­tion of drug prod­ucts, specif­i­cal­ly re­lat­ed to par­tic­u­lates from the met­al trays. It al­so not­ed de­fi­cien­cies in process­es and prac­tices sur­round­ing asep­tic pro­cess­ing.

The warn­ing let­ter from the FDA said that most of the tray units at the fa­cil­i­ty have suf­fered ap­par­ent dam­age and were al­so in­ad­e­quate for use in ster­ile drug pro­duc­tion. Emer­gent al­so lacked any specifics re­gard­ing its doc­u­ment ac­tiv­i­ties for the in­spec­tion, iden­ti­fi­ca­tion, seg­re­ga­tion, eval­u­a­tion, re­pair or re­tire­ment of de­fec­tive tray units.

While Emer­gent stat­ed to the FDA that it im­prove­ments to the pro­gram mon­i­tor­ing asep­tic pro­cess­ing per­son­nel be­hav­ior and class­room train­ing on asep­tic be­hav­iors the US reg­u­la­tor found that that re­sponse was not ad­e­quate.

The FDA rec­om­mend­ed to Emer­gent that it should re­view and as­sess its qual­i­ty man­age­ment sys­tem and en­gage a con­sul­tant to go over the com­pa­ny’s CGMP op­er­a­tions. In the SEC fil­ing, Emer­gent said it re­tained a third par­ty to con­duct an ad­di­tion­al re­view of the fa­cil­i­ty and to pro­vide over­sight of on­go­ing process­es at the Cam­den site.

“Bio­phar­ma­ceu­ti­cal man­u­fac­tur­ing is com­plex, and the stakes are high. That is why we have made sig­nif­i­cant in­vest­ments to up­grade our phys­i­cal ca­pa­bil­i­ties and are fo­cused on strength­en­ing our cul­ture of qual­i­ty and com­pli­ance. This is a process that doesn’t hap­pen overnight, but one to which we are com­mit­ted,” ac­cord­ing to a state­ment from Emer­gent.

Emer­gent did not re­spond to any fur­ther in­quiries from End­points News.

How­ev­er, this is not the first time the Mary­land-based man­u­fac­tur­er has crossed paths with the FDA. In April 2021, Emer­gent had to shut down pro­duc­tion at its Bayview fa­cil­i­ty and quar­an­tine any ex­ist­ing ma­te­ri­als in the wake of a John­son & John­son vac­cine man­u­fac­tur­ing fi­as­co. At the time, FDA in­ves­ti­ga­tors found the com­pa­ny’s qual­i­ty unit failed to en­sure ba­sic func­tions of its op­er­a­tions, in­clud­ing elec­tron­ic da­ta that were ma­nip­u­lat­ed and delet­ed, and qual­i­ty unit pro­ce­dures that had not been put in­to writ­ing, among an ar­ray of oth­er is­sues.

And it’s not the on­ly prob­lem that Emer­gent is deal­ing with. Last month, Emer­gent claimed that J&J that it will have to pay some­where in the range of $125 mil­lion to $420 mil­lion if J&J ter­mi­nates its Covid man­u­fac­tur­ing con­tract as the Big Phar­ma winds down its Covid-19 vac­cine op­er­a­tions be­fore ful­fill­ing the min­i­mum re­quire­ments in its con­tract with Emer­gent.

Ad­di­tion­al Emer­gent man­u­fac­tur­ing is­sues around the J&J vac­cine al­so are be­ing re­vealed in new con­gres­sion­al com­mit­tee find­ings re­leased last Thurs­day. It showed that 135 mil­lion more coro­n­avirus vac­cine dos­es man­u­fac­tured at Emer­gent’s Bal­ti­more-based fa­cil­i­ty for J&J were des­ig­nat­ed for de­struc­tion due to qual­i­ty de­fi­cien­cies. That brings the to­tal num­ber of dos­es wast­ed to north of 525 mil­lion.

Emer­gent has 15 days from Aug. 10 to re­spond to the FDA and they are en­cour­aged to cor­rect any vi­o­la­tions prompt­ly. Fail­ure to ad­dress the mat­ter may re­sult in reg­u­la­to­ry or le­gal ac­tion or the with­hold­ing of ex­port cer­tifi­cates, among oth­er ac­tions.

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