Gilead Sciences, Inc.
Form 483 issued January 22, 2024 · Foster City, California
- Inspection
- Jan 16 – Jan 22, 2024
- Investigators
- Cynthia J. Tsui· Scott N. Lim
- Observations
- 1
- Pages
- 4
- FEI number
- 1000523075
In short: On January 22, 2024, FDA issued a Form 483 with 1 observation to Gilead Sciences, Inc. in Foster City, California (FEI 1000523075) after an inspection that ran Jan 16 – Jan 22, 2024. The investigators were Cynthia J. Tsui and Scott N. Lim. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observation- 01
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA…
This inspection in context
Cynthia J. Tsui
2 documents · 2024–2026
Cites 312.50 (general responsibilities of sponsors) more than any other section. Most of their documents are for sites in California.
The firmGilead Sciences, Inc. history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 314.80(c)(1)(i)
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. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
Who inspected Gilead Sciences, Inc.?
Cynthia J. Tsui and Scott N. Lim are named on this Form 483, for the inspection of Jan 16 – Jan 22, 2024. Each investigator has a profile showing what they cite most.
When was Gilead Sciences, Inc. inspected by FDA?
The inspection ran Jan 16 – Jan 22, 2024, and the Form 483 is dated January 22, 2024.
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.