# FDA 483 - Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company - November 19, 2019

Source: https://www.keypedia.com/records/483/bristol-myers-squibb-holdings-pharma-ltd-liability-company/1a7ca172-8509-4f22-b87f-30ac950c30a1

> FDA 483 for Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company on November 19, 2019. 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: 2019-11-19
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company in Manati, PR, a sterile drug product manufacturer, revealed multiple significant deficiencies. These included failures in preventing microbiological contamination, inadequate laboratory record-keeping, and a deficient quality control unit. The facility also suffered from pest infestations and lacked proper written procedures for production and process controls, indicating systemic issues impacting drug product quality and purity.

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- [483 - 2017-09-11](https://www.keypedia.com/records/483/bristol-myers-squibb-holdings-pharma-ltd-liability-company/8e009935-5ba5-495d-8aa2-4f8de0e2e8ae)
- [483 - 2021-07-12](https://www.keypedia.com/records/483/bristol-myers-squibb-holdings-pharma-ltd-liability-company/3d31f49a-c3dd-4feb-9a88-ddfd46449760)

## Related Officers

- [Libia Lugo](https://www.keypedia.com/people/libia-lugo/55f1387e-b6bd-41ca-8507-45829629dac5)
- [Investigator](https://www.keypedia.com/people/regina-t-brown/6e2de1b6-3e5d-40ec-8823-7f0aef908b2b)

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/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9