Biomarin Pharmaceuticals Inc – FDA Inspection, Dec 6, 2016

Record Details

This FDA Inspection record concerns Biomarin Pharmaceuticals Inc, with an inspection on December 6, 2016, issued by the San Francisco District Office, covering human drugs.

Company: Biomarin Pharmaceuticals Inc
Inspection Date: December 6, 2016
Product Type: Human Drugs
Office: San Francisco District Office
People: Ashar P. Parikh
Lucila B. Nwatu (FDA Associated Person)
Rumany C. Penn (FDA Associated Person)

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ID · fcfc761b-3ba9-472d-9254-2f50523d5062

Inspection Facts

Inspection number: 1000920
FDA center: Human Drugs
Project area: Postmarket Surv. and Epidemiology
Outcome: Form 483 issued

FDA Citations

21 CFR 314.80(b)Failure to develop written procedures
21 CFR 314.80(c)(1)(i)Late submission of 15-day report

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FDA Inspection

Biomarin Pharmaceuticals IncDecember 6, 2016