# FDA 483 - BioMarin Pharmaceutical, Inc. - April 02, 2021

Source: https://www.keypedia.com/records/483/biomarin-pharmaceutical-inc/1e97f714-134a-473e-8ca8-bbb33d74dfd1

> FDA 483 for BioMarin Pharmaceutical, Inc. on April 02, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioMarin Pharmaceutical, Inc.
- Inspection Date: 2021-04-02
- Product Type: drugs
- Office Name: Office of Compliance Intervention and Consultation
- Summary: An FDA Form 483 was issued to an unnamed firm following an inspection, for which the specific dates were not provided in the document. The inspection identified two significant observations related to the firm's quality control processes. The first observation highlighted the absence of a written established procedure for requesting and shipping samples to control laboratories for testing of cell banks, drug substance, and drug product. An example cited involved errors in specification document numbers and reconstitution volume on a sample information sheet sent to a contract laboratory for stability testing of specific BMN111 lots, indicating a lack of a verification process before sending test forms and samples. The second observation noted the firm's lack of a written procedure governing the receipt, review, and filing of test results from contract laboratories. Results were received via email or retrieved from contract laboratory portals and distributed via email to quality teams, indicating a lack of control over these crucial documents. These observations, issued pursuant to Section 704(b) of the Federal Food, Drug, and Cosmetic Act, indicate conditions and practices that require the firm's attention to ensure compliance with regulatory standards. The firm is expected to address these deficiencies by implementing corrective actions and can discuss these with the FDA.

## Related Documents

- [EIR - 2018-11-09](https://www.keypedia.com/records/eir/biomarin-pharmaceutical-inc/d68114e4-98af-4ad9-9a84-ee2c914e8a3a)
- [EIR - 2017-12-14](https://www.keypedia.com/records/eir/biomarin-pharmaceutical-inc/ed544e08-f6aa-4d9c-afdc-7ea7c99813dd)
- [483 - 2021-04-02](https://www.keypedia.com/records/483/biomarin-pharmaceutical-inc/68119bf5-5042-4336-9c03-7fde3f113010)
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- [483 - 2014-04-17](https://www.keypedia.com/records/483/biomarin-pharmaceutical-inc/cae106c6-e26b-4552-bd9f-10fa67375f17)

## Related Officers

- [Hung H. Do, MS, Investigator](https://www.keypedia.com/people/hung-h-do-ms-investigator/10232463-1d06-4ab9-be24-3bd9343ebcec)
- [Uttaniti Limchumroon](https://www.keypedia.com/people/uttaniti-limchumroon/ce890cbf-2f5c-498f-917c-0edf8b10d356)

Company: https://www.keypedia.com/companies/biomarin-pharmaceutical-inc/7811b401-4321-4df1-b9b5-deef8905c101

Office: https://www.keypedia.com/offices/office-of-compliance-intervention-and-consultation/0b3cfe41-f423-41e0-b1a1-caab23b32d54