# FDA 483 - BioMarin International Limited - December 13, 2024

Source: https://www.keypedia.com/records/483/biomarin-international-limited/917a7038-2076-48ce-bf7b-82b3c1692b0b

> FDA 483 for BioMarin International Limited on December 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioMarin International Limited
- Inspection Date: 2024-12-13
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Biolnlarin International Limited, a drug product manufacturer in Ringaskiddy, Ireland, was cited for significant deficiencies during an FDA inspection. Observations included poor aseptic practices and inadequate environmental controls for sterile drug product manufacturing, a failure to thoroughly investigate and trend microbiological contamination, and inadequate laboratory controls for environmental monitoring. These issues indicate a high severity regarding potential product contamination and quality control failures.

## Related Documents

- [483 - 2017-05-02](https://www.keypedia.com/records/483/biomarin-international-limited/fd3565b7-22be-41a7-813e-b507094c8886)
- [483 - Unknown Date](https://www.keypedia.com/records/483/biomarin-international-limited/a6c14a38-796a-49d1-b12e-03d5e5ad6540)

## Related Officers

- [Erin Wall, Ph.D., ITJ Biologics Quality Assessor](https://www.keypedia.com/people/erin-wall-phd-itj-biologics-quality-assessor/1d88a09f-6050-4625-84d7-7440a6029b80)
- [Jennifer Voehnhof, Ph.D., Pharmaceutical Scientist](https://www.keypedia.com/people/jennifer-voehnhof-phd-pharmaceutical-scientist/5119d2ec-0743-49ab-950a-0b9d069431d1)
- [Melissa Ray, Ph.D., Microbiologist](https://www.keypedia.com/people/melissa-ray-phd-microbiologist/f737d5d7-f769-4db6-bc2c-b38cd8430f54)
- [Thuy Thanh Nguyen, DHSc, Branch Chief](https://www.keypedia.com/people/thuy-thanh-nguyen-dhsc-branch-chief/597b8ce7-1f51-4ede-b114-14df8bff3e01)
- [Melissa D. Ray](https://www.keypedia.com/people/melissa-d-ray/d3edab82-132c-4a8f-997a-19d610a4f03a)

Company: https://www.keypedia.com/companies/biomarin-international-limited/dbd5911b-3dec-4a03-a980-1e45a5f973a4

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8