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# FDA-483 Posted on BMS Liso-cel Pre-approval Inspection
- URL: https://www.fdaweb.com/fda-483-posted-on-bms-liso-cel-pre-approval-inspection/
- Published: 2021-01-15T12:00:00.000Z
- Updated: 2026-09-14T16:42:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148463

An FDA inspection last month at Lonza’s Viral Vector contract-manufacturing facility in Houston, TX, resulted in a four-item FDA-483, but more importantly it released an FDA review hold on 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. In November, the agency told BMS that it would not complete the BLA review by the 11/16 user 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.

The [just-posted FDA-483](https://www.fda.gov/media/145127/download?ref=fdaweb.com) cited Lonza’s physical and electronic control of material storage areas as not being adequate. For example, there is no separate storage area for different undisclosed products to prevent mix-ups. The inspection also said that the identity of each incoming batch of certain raw materials is not verified and tested to confirm their identity prior to release for manufacturing. Additionally, FDA found that the facility’s written procedures are not always followed, and that its microbial contamination controls are not adequate.

In a [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) earlier this month, BMS said that after the inspection 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.