Gilead Sciences Inc.
FDA inspection history in San Dimas, California, 2010
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2010: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010One warning letter and one Form 483, at San Dimas, California.
Cited most
Across all Gilead Sciences observations on file
- 21 CFR 211.42(c)(10)Design and construction features3
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.165(d)Testing and release for distribution1
- 21 CFR 211.180(e)(1)General requirements1
The complete Gilead Sciences file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
San Dimas, California
One warning letter and one Form 483 · 2010 · 10 observations
Latest: Warning letter, Sep 21, 2010 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2010-09-21 | Warning letter Warning letter | San Dimas, California | — | $99 |
| 2010-02-12 | 483 Form 483 | San Dimas, California | 10 | $99 |
Investigators on these documents
FEI number 2082946 · most recent document Sep 21, 2010
About Gilead Sciences Inc.
How many FDA Form 483s has Gilead Sciences Inc. received?
FDA Intel has 1 Form 483 on file for Gilead Sciences Inc.; the most recent is dated Feb 12, 2010.
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 Feb 12, 2010, for the site in San Dimas, 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 211.42(c)(10) (Design and construction features), 3 times; 21 CFR 211.113(b) (Control of microbiological contamination), 2 times; 21 CFR 211.160(b) (General requirements), 1 time.
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 Sep 21, 2010.