BioMarin Pharmaceutical Inc.
Form 483 issued December 9, 2022 · Novato, California
- Inspection
- Dec 5 – Dec 9, 2022
- Investigators
- Andrew Harmon· Emmanuel Adu-Gyamfi· Kula Jha
- Observations
- 2
- Pages
- 3
- FEI number
- 3004079983
In short: On December 9, 2022, FDA issued a Form 483 with 2 observations to BioMarin Pharmaceutical Inc. in Novato, California (FEI 3004079983) after an inspection that ran Dec 5 – Dec 9, 2022. The investigators were Andrew Harmon, Emmanuel Adu-Gyamfi, Kula Jha, Laura Fontan and Thomas R. Withers. Most observations concern production and biologics CGMP; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and biologics cgmp account for 2 of 2 observations.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures are incorrect and lack specific instruction to perform operations consistently, in the _…
- 02
(b) (4) does not…
This inspection in context
Andrew Harmon
1 document · 2022
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
The firmBioMarin Pharmaceutical Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BioMarin Pharmaceutical Inc.?
FDA listed 2 observations on this Form 483, mostly about production and biologics CGMP. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected BioMarin Pharmaceutical Inc.?
Andrew Harmon, Emmanuel Adu-Gyamfi, Kula Jha, Laura Fontan and Thomas R. Withers are named on this Form 483, for the inspection of Dec 5 – Dec 9, 2022. Each investigator has a profile showing what they cite most.
When was BioMarin Pharmaceutical Inc. inspected by FDA?
The inspection ran Dec 5 – Dec 9, 2022, and the Form 483 is dated December 9, 2022.
How do I get the full Form 483 for BioMarin Pharmaceutical Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.