Gilead Sciences, Inc.
Form 483 issued December 9, 2011 · Foster City, California
- Inspection
- Dec 5 – Dec 9, 2011
- Investigators
- Arindam Dasgupta· Kevin P. Foley
- Observations
- 2
- Pages
- 1
- FEI number
- 1000523075
In short: On December 9, 2011, FDA issued a Form 483 with 2 observations to Gilead Sciences, Inc. in Foster City, California (FEI 1000523075) after an inspection that ran Dec 5 – Dec 9, 2011. The investigators were Arindam Dasgupta and Kevin P. Foley. Most observations concern gLP; the most-cited regulation is 21 CFR 58.130 (conduct of a nonclinical laboratory study).
At a glance
2 of 2 observations on this 483 concern glp.
Most cited: 21 CFR 58.190 (1×) · 58.130 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to conduct a re-injection reprodt eriment during pre-study method validation for (MAMMPmethod. Samples for subject…
- 02
Failure to document all…
This inspection in context
Arindam Dasgupta
1 document · 2011
Cites 58.130 (conduct of a nonclinical laboratory study) 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 58.190
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Gilead Sciences, Inc.?
FDA listed 2 observations on this Form 483, mostly about gLP. The most-cited regulation is 21 CFR 58.130 (conduct of a nonclinical laboratory study). The opening words of each observation are shown on this page.
Who inspected Gilead Sciences, Inc.?
Arindam Dasgupta and Kevin P. Foley are named on this Form 483, for the inspection of Dec 5 – Dec 9, 2011. Each investigator has a profile showing what they cite most.
When was Gilead Sciences, Inc. inspected by FDA?
The inspection ran Dec 5 – Dec 9, 2011, and the Form 483 is dated December 9, 2011.
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.