The FDA wrapped up its in­spec­tion of Emer­gent’s trou­bled vac­cine man­u­fac­tur­ing plant in Bal­ti­more on Tues­day, af­ter halt­ing pro­duc­tion there on Mon­day. By Wednes­day morn­ing, the agency al­ready re­leased a se­ries of scathing ob­ser­va­tions on the cross con­t­a­m­i­na­tion, san­i­tary is­sues and lack of staff train­ing that caused the con­tract man­u­fac­tur­er to dis­pose of mil­lions of As­traZeneca and J&J vac­cine dos­es.

The first of nine ob­ser­va­tions in the Form 483, fol­low­ing a nine-day in­spec­tion, deals with the fact that Emer­gent failed to thor­ough­ly in­ves­ti­gate the vac­cine drug sub­stance mix-up that caused the firm to throw away 15 mil­lion dos­es of the J&J vac­cine.

“There is no as­sur­ance that oth­er batch­es have not been sub­ject to cross-con­t­a­m­i­na­tion,” the FDA writes.

The sec­ond ob­ser­va­tion deals with the fact that the fa­cil­i­ty is filthy.

In ad­di­tion to chip­ping paint on the walls and floors that mean the sur­faces can­not be ad­e­quate­ly cleaned, FDA notes that waste gen­er­at­ed dur­ing the man­u­fac­ture of vac­cine drug sub­stance is not de­con­t­a­m­i­nat­ed be­fore be­ing trans­port­ed through the ware­house and ad­ja­cent ar­eas.

Ac­cord­ing to se­cu­ri­ty cam­era footage, em­ploy­ees in one of the man­u­fac­tur­ing ar­eas in Jan­u­ary and Feb­ru­ary were “ob­served throw­ing un­sealed bags of spe­cial med­ical waste in­to the ser­vice el­e­va­tor ac­cess­ing the ware­house cor­ri­dor,” the 483 notes. The third ob­ser­va­tion al­so raised con­cerns about the size of the fa­cil­i­ty, which was over­crowd­ed with ma­te­ri­als read­ied to be man­u­fac­tured.

Em­ploy­ees were al­so ob­served in Feb­ru­ary and as re­cent­ly as mid-April drag­ging un­sealed bags of med­ical waste from one man­u­fac­tur­ing area across the floor to the ware­house, as well as re­mov­ing pro­tec­tive gar­ments on­to the ware­house floor where raw ma­te­ri­als were be­ing read­ied for man­u­fac­ture.

The fifth and sixth ob­ser­va­tions note that Emer­gent did not prop­er­ly han­dle and store vi­ral bulk drug sub­stances to pre­vent cross con­t­a­m­i­na­tion and did not have prop­er pro­ce­dures for de­con­t­a­m­i­nat­ing waste.

Emer­gent’s fail­ure to train em­ploy­ees is doc­u­ment­ed in the sev­enth ob­ser­va­tion, which notes per­son­nel in­volved in the man­u­fac­tur­ing op­er­a­tions en­tered in­to the man­u­fac­tur­ing area while pro­cess­ing of some bulk drug sub­stance was tak­ing place, and then en­tered oth­er op­er­a­tional rooms with­out prop­er­ly ad­her­ing to gown­ing pro­ce­dures.

“Per­son­nel in­volved in man­u­fac­tur­ing op­er­a­tions dragged non-dis­in­fect­ed and non-de­con­t­a­m­i­nat­ed spe­cial med­ical waste” from one man­u­fac­tur­ing area across the ware­house cor­ri­dor, FDA not­ed.

FDA said in a state­ment Wednes­day, “At the agency’s re­quest, Emer­gent BioSo­lu­tions has agreed to pause new pro­duc­tion while it works with the FDA to re­solve po­ten­tial qual­i­ty is­sues. For the vac­cines al­ready man­u­fac­tured, the prod­ucts will un­der­go ad­di­tion­al test­ing and will be thor­ough­ly eval­u­at­ed to en­sure their qual­i­ty be­fore any po­ten­tial dis­tri­b­u­tion.”

The agency raised sim­i­lar con­cerns with the plant, fol­low­ing an in­spec­tion in April 2020.

Emer­gent said in a state­ment that it’s com­mit­ted to “work­ing with the FDA and John­son & John­son to quick­ly re­solve the is­sues iden­ti­fied.”

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

As Johnson & Johnson continues to roll out its Covid-19 shot, the company is also focused on another vaccine.

J&J is donating up to 200,000 doses of its Ebola vaccine regimen developed with Bavarian Nordic to help health authorities deal with a new outbreak in Sierra Leone. The regimen, Zabdeno and Mvabea, was granted prequalification by the WHO in April, which will help accelerate its registration in countries where Ebola is a threat.