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.”

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.