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.”

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Oyster Point Pharma now has its first FDA-approved product — Tyrvaya. And the biotech has taken a unique route to get there by using an old drug with a storied past.

The New Jersey biotech announced this morning that the FDA has approved their nasal spray product for dry eye disease on Friday — the first nasal spray to be approved for the disease. The product’s active ingredient is 0.03 mg of varenicline, also known as smoking cessation aid Chantix.

Omeros practically warned investors that a complete response letter was coming when it disclosed that the FDA found deficiencies in its BLA for narsoplimab. But the agency did not elaborate on the specifics of those deficiencies for the drug, which was being positioned as a treatment for the rare but serious blood clotting disease known as hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

If at first you don’t succeed, and at second you don’t succeed, try, try again.

That’s been the unofficial mantra for Adamis Pharmaceuticals’ high dose naloxone injection, which received two CRLs in the span of a year between the Novembers of 2019 and 2020. But on Monday, word came through that the FDA approved the drug on Adamis’ third attempt, giving doctors another tool to treat individuals who overdose on opioids.