Gilead Sciences, Inc.
FDA inspection history in Foster City, California, 2003 to 2024
- 6
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2003: one warning letter; 2011: two Form 483s; 2013: one Form 483; 2018: one Form 483; 2020: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2003One warning letter, at Foster City, California.
- 2011–13Three Form 483s, at Foster City, California.
- 2013The longest 483 on file: 9 observations over 10 pages at Foster City, California.
- 2018–20Two Form 483s, at Foster City, California.
- 2024One Form 483, at Foster City, California.
Cited most
Across all Gilead Sciences observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.194Laboratory records2
- 21 CFR 314.80(c)(1)(i)Postmarketing reporting of adverse drug experiences2
- 21 CFR 111
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
The complete Gilead Sciences file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Foster City, California
Six Form 483s and one warning letter · 2003 to 2024 · 16 observations
Latest: Form 483, Jan 22, 2024 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-01-22 | 483 Form 483 | Foster City, California | 1 | $99 |
| 2020-07-22 | 483 Form 483 | Foster City, California | 2 | $99 |
| 2018-07-17 | 483 Form 483 | Foster City, California | 1 | $99 |
| 2013-04-26 | 483 Form 483 | Foster City, California | 9 | $99 |
| 2011-12-09 | 483 Form 483 | Foster City, California | 2 | $99 |
| 2011-10-18 | 483 Form 483 | Foster City, California | 1 | $99 |
| 2003-07-29 | Warning letter Warning letter | Foster City, California | — | $99 |
Investigators on these documents
Arindam Dasgupta (1)Carl Lee (1)Cynthia J. Tsui (1)Daniel J. Roberts (1)Kevin P. Foley (1)Scott N. Lim (1)Thomas Cruse (1)
FEI number 1000523075 · most recent document Jan 22, 2024
About Gilead Sciences, Inc.
How many FDA Form 483s has Gilead Sciences, Inc. received?
FDA Intel has 6 Form 483s on file for Gilead Sciences, Inc.; the most recent is dated Jan 22, 2024.
When was Gilead Sciences, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Gilead Sciences, Inc. is a Form 483 dated Jan 22, 2024, for the site in Foster City, California.
What did FDA cite at Gilead Sciences, Inc.?
The regulations cited most in the observations on file for Gilead Sciences, Inc. are 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.194 (Laboratory records), 2 times; 21 CFR 314.80(c)(1)(i) (Postmarketing reporting of adverse drug experiences), 2 times.
Has Gilead Sciences, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Gilead Sciences, Inc.; the most recent is dated Jul 29, 2003.