An FDA in­spec­tion re­port on Te­va’s man­u­fac­tur­ing site in New Jer­sey has re­vealed is­sues with both equip­ment clean­ing and qual­i­ty.

The three-page re­port, which was ob­tained by End­points News via a FOIA re­quest from the FDA, showed sev­er­al ob­ser­va­tions from its in­spec­tion, which took place be­tween Nov. 1 and Nov. 10 of last year, at Te­va’s site in Fair­field, NJ.

In­spec­tors not­ed a buildup of “un­known residue” with­in two pro­duc­tion rooms that had been doc­u­ment­ed as cleaned. Specif­i­cal­ly, a pink- or red-col­ored residue was found on equip­ment in the mix­ing room that had most re­cent­ly been used to man­u­fac­ture Ce­fadrox­il tablets. Ce­fadrox­il, which is used to treat bac­te­r­i­al in­fec­tions in var­i­ous parts of the body, does not use any dyes or fla­vor­ings.

Pre­vi­ous­ly, the same equip­ment al­so pro­duced sev­er­al batch­es of Cephalex­in, an­oth­er an­tibi­ot­ic which does in­clude a cher­ry fla­vor­ing and a red dye, FDA said. Cephalex­in is used to treat pneu­mo­nia, res­pi­ra­to­ry in­fec­tions and oth­ers.

The re­port al­so in­di­cates that sev­er­al oth­er ar­eas of the mix­ing room con­tained un­known residue, in­clud­ing a work­sta­tion and sev­er­al blenders, one of which had pre­vi­ous­ly been used to make Cephalex­in cap­sules.

The in­spec­tion re­port al­so said that some Cephalex­in tablets had two com­plaints at­tached, which was part of a larg­er in­ves­ti­ga­tion in­to “de­fec­tive coat­ing.” As part of the in­ves­ti­ga­tion, the batch was sub­ject­ed to oth­er tests, but was al­so run through screen­ing equip­ment that was not doc­u­ment­ed as “qual­i­fied with tablet prod­ucts.” The re­port and the stan­dard op­er­at­ing prac­tices don’t give de­tails on the screen­ing of tablets. While over 34,000 tablets were re­ject­ed, the re­main­ing tablets that were scanned were re­leased for dis­tri­b­u­tion in the US in 2018.

Te­va al­so re­ceived 30 com­plaints re­lat­ed to de­fec­tive coat­ings on Cephalex­in be­tween Nov. 2018 and March 2021. Coat­ing en­hance­ments were rec­om­mend­ed, while the im­ple­men­ta­tion of these en­hance­ments is still pend­ing, ac­cord­ing to the re­port.

End­points reached out to Te­va for a state­ment on this re­port but did not re­ceive a re­sponse by press time.

Te­va’s man­u­fac­tur­ing sites have been un­der the FDAs mi­cro­scope in the past.

In 2021, in­ves­ti­ga­tors un­veiled sev­er­al prob­lems at a Te­va Phar­ma­ceu­ti­cals plant in Irvine, CA, in­clud­ing mold stem­ming from wa­ter leaks. Te­va halt­ed pro­duc­tion at that site, which even­tu­al­ly led to the re­call of 2.5 mil­lion vials of drugs, ac­cord­ing to a Bloomberg re­port.

That site was shut­tered in Au­gust of 2022, with 305 peo­ple be­ing laid off.

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.