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# Celgene Cell Therapy Facility Hit with Form 483
- URL: https://www.fdaweb.com/celgene-cell-therapy-facility-hit-with-form-483/
- Published: 2026-04-29T12:00:00.000Z
- Updated: 2026-09-14T13:38:19.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5161064

FDA has cited significant manufacturing and quality control concerns at a Celgene cell therapy facility in New Jersey, including deficiencies in sterile processing, environmental monitoring, and facility maintenance. The observations were detailed in a just-released [FDA Form 483](https://www.fda.gov/media/192234/download?attachment&ref=fdaweb.com) issued following an inspection conducted last year at the company’s Summit, NJ site, which manufactures cell therapy products including CAR-T treatments.

Agency investigators identified multiple lapses in aseptic technique, including failures by operators to properly disinfect gloves and materials before entering biological safety cabinets, a critical step to prevent microbial contamination. In some cases, personnel were observed reaching into sterile processing areas without appropriate sanitization or precautions, and deviations from standard operating procedures were documented during the manufacture of products such as Abecma and Breyanzi, according to the 483.

FDA also cited shortcomings in how the company investigated manufacturing deviations. According to the report, Celgene did not fully assess the impact of a 2023 contamination-related event on product quality, relying primarily on sterility test results while failing to account for broader environmental control issues.

In addition, inspectors found that certain production changes—such as the movement of materials between areas—were not consistently documented in batch records, raising concerns about traceability and compliance with good manufacturing practices.

Deficiencies were also noted in environmental monitoring systems, according to the 483\. FDA said some particulate excursions in cleanroom environments were not investigated or recorded as deviations, despite occurring in batches of both Abecma and Breyanzi. Inspectors further observed improperly positioned monitoring equipment, which could lead to underreporting of airborne particulates. Procedural practices that allowed certain environmental excursions to be dismissed without investigation were also criticized, along with insufficient qualification of production environments following prior contamination events.

The agency raised concerns about broader quality management practices, including the cancellation of hundreds of deviation reports without adequate root cause analysis. Between 6/2023 and 7/2025, the company canceled 458 deviations, some involving missing documentation or particulate contamination, without fully evaluating their impact, according to the report.

Additionally, inspectors documented physical deficiencies at the facility, including damaged flooring, worn surfaces, and areas that were difficult to clean — conditions that could compromise sterile manufacturing environments. Some issues had been previously identified but remained unresolved despite multiple work orders, according to the report. FDA also cited inadequate equipment qualification, including systems used to support cell culture processes, and changes to certain utility systems had not been fully validated, with some equipment continuing to be used without complete qualification.