Gilead Sciences, Inc.
Form 483 issued September 16, 2022 · La Verne, California
- Inspection
- Sep 12 – Sep 16, 2022
- Investigator
- Nicholas L. Hunt
- Observations
- 1
- Pages
- 3
- FEI number
- 3013189568
In short: On September 16, 2022, FDA issued a Form 483 with 1 observation to Gilead Sciences, Inc. in La Verne, California (FEI 3013189568) after an inspection that ran Sep 12 – Sep 16, 2022. The investigator was Nicholas L. Hunt. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The establishment of specifications, standards and test procedures including any changes thereto, are not drafted by…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
The firmGilead Sciences, Inc. history
All 5 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 Gilead Sciences, Inc.?
FDA listed 1 observation 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 Gilead Sciences, Inc.?
Nicholas L. Hunt is named on this Form 483, for the inspection of Sep 12 – Sep 16, 2022. Each investigator has a profile showing what they cite most.
When was Gilead Sciences, Inc. inspected by FDA?
The inspection ran Sep 12 – Sep 16, 2022, and the Form 483 is dated September 16, 2022.
How do I get the full Form 483 for Gilead Sciences, 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.