# FDA 483 - Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company - July 12, 2021

Source: https://www.keypedia.com/records/483/bristol-myers-squibb-holdings-pharma-ltd-liability-company/3d31f49a-c3dd-4feb-9a88-ddfd46449760

> FDA 483 for Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company on July 12, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company
- Inspection Date: 2021-07-12
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company received a Form 483 citing significant deficiencies across its quality systems, laboratory controls, and manufacturing processes. Key issues include data integrity failures, inadequate quality unit oversight, microbiological contamination risks, and insufficient design verification for combination products. The firm also struggled with pest control and proper handling of incoming materials, indicating systemic control weaknesses.

## Related Documents

- [483 - 2017-09-11](https://www.keypedia.com/records/483/bristol-myers-squibb-holdings-pharma-ltd-liability-company/8e009935-5ba5-495d-8aa2-4f8de0e2e8ae)
- [483 - 2019-11-19](https://www.keypedia.com/records/483/bristol-myers-squibb-holdings-pharma-ltd-liability-company/1a7ca172-8509-4f22-b87f-30ac950c30a1)

## Related Officers

- [Jose F. Velez](https://www.keypedia.com/people/jose-f-velez/0d1951e8-3aa5-48ff-bc54-1fae8a7a57c9)
- [Adaliz Santaliz-Cruz](https://www.keypedia.com/people/adaliz-santaliz-cruz/47bd4220-e6cc-4582-a4f5-bd4337f92622)
- [Libia Lugo](https://www.keypedia.com/people/libia-lugo/55f1387e-b6bd-41ca-8507-45829629dac5)

Company: https://www.keypedia.com/companies/bristol-myers-squibb-holdings-pharma-ltd-liability-company/64a65e7b-7328-491c-8b08-cc8f2e018968

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