BioMarin Pharmaceutical Inc.
Form 483 issued April 2, 2021 · Novato, California
- Inspection
- Apr 2, 2021
- Investigator
- Uttaniti Limchumroon
- Observations
- 2
- Pages
- 2
- FEI number
- 3004079983
In short: On April 2, 2021, FDA issued a Form 483 with 2 observations to BioMarin Pharmaceutical Inc. in Novato, California (FEI 3004079983) after an inspection that ran Apr 2, 2021. The investigator was Uttaniti Limchumroon. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm does not have a written established procedure for requesting and shipping samples to the…
- 02
Your firm does not have a written procedure governing the process of receiving, reviewing, and filing…
This inspection in context
Uttaniti Limchumroon
20 documents · 2015–2021
Cites 211.42 (design and construction features) 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 211.160
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 laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected BioMarin Pharmaceutical Inc.?
Uttaniti Limchumroon is named on this Form 483, for the inspection of Apr 2, 2021. Each investigator has a profile showing what they cite most.
When was BioMarin Pharmaceutical Inc. inspected by FDA?
The inspection ran Apr 2, 2021, and the Form 483 is dated April 2, 2021.
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.