The gener­ics man­u­fac­tur­er Lupin has been giv­en an­oth­er Form 483 from the FDA this year.

US reg­u­la­tors in­spect­ed Lupin’s phar­ma­ceu­ti­cal man­u­fac­tur­ing site in the town of Man­dideep, In­dia from Nov. 14 through Nov. 23, with the 14-page re­port mark­ing 16 ob­ser­va­tions.

The in­spec­tion re­port stat­ed that the site did not have the ap­pro­pri­ate con­trols over its com­put­er sys­tems to en­sure that changes in “mas­ter pro­duc­tion” or records are on­ly done by au­tho­rized per­son­nel, along with writ­ten pro­ce­dures not be­ing es­tab­lished to con­duct an­nu­al re­views of records as­so­ci­at­ed with drug batch­es.

In­spec­tors al­so not­ed that the site had 68 bags filled with “shred­ded doc­u­ments” at the site’s trash col­lec­tion area. But the site didn’t have an ad­e­quate­ly de­scribed process for which GMP doc­u­ments should be shred­ded.

The “rou­tine cal­i­bra­tion” of au­to­mat­ic and me­chan­i­cal equip­ment was al­so not done. Pro­ce­dures for the qual­i­ty con­trol unit were not in writ­ing and not be­ing ful­ly fol­lowed.

For ob­ser­va­tions re­lat­ed to ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (APIs), in­spec­tors found that “crit­i­cal process pa­ra­me­ters” in the man­u­fac­tur­ing of in­gre­di­ents were not be­ing con­tin­u­ous­ly mon­i­tored. Com­put­er sys­tems did not have “suf­fi­cient con­trols” to pre­vent changes to da­ta or unau­tho­rized ac­cess. A num­ber of oth­er spe­cif­ic ob­ser­va­tions re­lat­ed to en­gi­neer­ing prac­tices and oth­er pro­ce­dures.

End­points News reached out to Lupin for com­ment on the in­spec­tion and oth­er de­tails but did not re­ceive a re­sponse by press time.

This is not the first time this year that Lupin has been un­der the mi­cro­scope from the FDA. An in­spec­tion from Oct.3 to Oct. 14 of this year, at Lupin’s biosim­i­lar man­u­fac­tur­ing fa­cil­i­ty in Pune, In­dia, had 10 ob­ser­va­tions not­ed. Some of the items not­ed by FDA in­spec­tors in­clud­ed not ap­pro­pri­ate­ly eval­u­at­ing for a mi­cro­bial con­t­a­m­i­na­tion and pro­tec­tive ap­par­el that was not al­ways be­ing worn.

Lupin has al­so been hand­ed down a warn­ing let­ter this year as well. The let­ter re­ceived in Oc­to­ber not­ed that it had sus­pend­ed the pro­duc­tion of drugs for the US mar­ket and must no­ti­fy the FDA if it wants to restart mak­ing drugs for the US.

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.