Gilead Sciences, Inc.
Form 483 issued April 26, 2013 · Foster City, California
- Inspection
- Apr 10 – Apr 26, 2013
- Investigators
- Carl Lee· Thomas Cruse
- Observations
- 9
- Pages
- 10
- FEI number
- 1000523075
In short: On April 26, 2013, FDA issued a Form 483 with 9 observations to Gilead Sciences, Inc. in Foster City, California (FEI 1000523075) after an inspection that ran Apr 10 – Apr 26, 2013. The investigators were Carl Lee and Thomas Cruse. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
6 of 9 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (2×) · 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
The accuracy, sensitivity, specificity, and reproducibility of test methods…
- 02
The suitability of all testing methods is not verified under…
- 03
The use of instruments not meeting…
- 04
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Carl Lee
2 documents · 2011–2013
Cites 211.160 (general requirements) 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 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Gilead Sciences, Inc.?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Gilead Sciences, Inc.?
Carl Lee and Thomas Cruse are named on this Form 483, for the inspection of Apr 10 – Apr 26, 2013. Each investigator has a profile showing what they cite most.
When was Gilead Sciences, Inc. inspected by FDA?
The inspection ran Apr 10 – Apr 26, 2013, and the Form 483 is dated April 26, 2013.
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.