# FDA 483 - Bristol-Myers Squibb Company - February 19, 2021

Source: https://www.keypedia.com/records/483/bristol-myers-squibb-company/de025911-4ac0-4553-854c-d1edad23420a

> FDA 483 for Bristol-Myers Squibb Company on February 19, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bristol-Myers Squibb Company
- Inspection Date: 2021-02-19
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Celgene Corporation, a Bristol Myers Squibb Company, a CAR-T Cell Manufacturer in Summit, NJ, was cited for three observations during an FDA inspection. The observations primarily concern inadequate aseptic practices leading to potential microbial contamination, failures within the quality control unit regarding material storage and temperature monitoring, and a lack of written procedures for managing escalated deviations and product recalls. These issues indicate significant deficiencies in maintaining product quality and regulatory compliance.

## Related Documents

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- [EIR - 2022-03-14](https://www.keypedia.com/records/eir/bristol-myers-squibb-company/d539f239-1103-4fe2-acdf-a6f28938d6e1)
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## Related Officers

- [investigator](https://www.keypedia.com/people/kimberly-l-schultz/2d000290-f49c-4cfd-b8f8-3f4d71f76324)
- [Linda Thur, CSO](https://www.keypedia.com/people/linda-thur-cso/4f1069c7-1580-424a-a86c-15b104652464)
- [Regulatory Project Manager](https://www.keypedia.com/people/nimmy-mathews/9eac44d1-5e4c-493a-89c5-c7414a5a4037)
- [Anna Conley](https://www.keypedia.com/people/anna-conley/c4e548c2-65c1-4225-af38-e93529002757)
- [Anna Kivile](https://www.keypedia.com/people/anna-kivile/f4cf8dfa-4ab8-4cfe-8101-98f9c1d17c0e)

Company: https://www.keypedia.com/companies/bristol-myers-squibb-company/3734a119-014f-49c6-b518-fc8b1dea7f92

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab