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# FDA Inspection Releases Review Hold on BMS’ Liso-cel
- URL: https://www.fdaweb.com/fda-inspection-releases-review-hold-on-bms-liso-cel/
- Published: 2021-01-07T12:00:00.000Z
- Updated: 2026-09-14T16:41:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148396

FDA is continuing its review of a Bristol-Myers Squibb (BMS) BLA for lisocabtagene maraleucel (liso-cel), indicated for treating adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies, following the completion of an inspection at third-party manufacturer Lonza. In November, the agency told the company that it would not complete BLA review by the 11/16 PDUFA action date. The company [said](https://www.businesswire.com/news/home/20201116006018/en/Bristol-Myers-Squibb-Provides-Regulatory-Update-on-Lisocabtagene-Maraleucel-liso-cel?ref=fdaweb.com) at the time that FDA was unable to inspect the facility due to the Covid-19 pandemic.

In a [new statement](https://news.bms.com/news/corporate-financial/2021/Bristol-Myers-Squibb-Statement-on-Status-of-Liso-cel-Application-and-Contingent-Value-Rights/default.aspx?ref=fdaweb.com), BMS said the inspection of the viral Lonza manufacturing plant took place from 12/3 to 12/10 and that both firms “expeditiously responded to observations received at the close of the inspection within eight days.” Additionally, “BMS received information requests which were also rapidly responded to and there are currently no outstanding information requests at this time,” the statement said. Late last year, BMS was also hit with a related six-observation FDA-483 ([see story](https://www.fdaweb.com/juno-therapeutics-fda-483/)) after an inspection at Juno Therapeutics, Bothell, WA, which the company controls after its acquisition of Celgene.

The BMS inspection delay served as the poster child for criticism ([see story](https://www.fdaweb.com/fda-faulted-on-inspection-alternatives/)) by former FDA Office of Compliance and Biologics Quality deputy director and now-Hyman, Phelps & McNamara director **Mark I. Schwartz** when he penned an [article](https://news.bloomberglaw.com/health-law-and-business/fda-fiddles-with-remote-drug-inspections-while-pharma-burns?ref=fdaweb.com) at *BloombergLaw.com*, calling on FDA to find alternatives to a physical inspection to prevent shortages of front-line drugs for treating Covid-19 patients and other lifesaving medications. “Without these inspections, new, cutting-edge therapies are being deferred or rejected, and drug shortages are worsening, including for front-line drugs in the treatment of Covid-19 patients,” he wrote. “The FDA should have been able to determine the facility’s compliance status by other means, particularly since the agency had tacitly acknowledged that the facility met its definition of a ‘mission critical’ inspection, suggesting that the FDA needed to perform the inspection despite the pandemic,” Schwartz said.