Gilead Sciences, Inc.
Form 483 issued October 18, 2011 · Foster City, California
- Inspection
- Oct 11 – Oct 18, 2011
- Investigator
- Daniel J. Roberts
- Observations
- 1
- Pages
- 1
- FEI number
- 1000523075
In short: On October 18, 2011, FDA issued a Form 483 with 1 observation to Gilead Sciences, Inc. in Foster City, California (FEI 1000523075) after an inspection that ran Oct 11 – Oct 18, 2011. The investigator was Daniel J. Roberts. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations from written sampling plans are…
This inspection in context
Daniel J. Roberts
14 documents · 2011–2017
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.160
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, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Gilead Sciences, Inc.?
Daniel J. Roberts is named on this Form 483, for the inspection of Oct 11 – Oct 18, 2011. Each investigator has a profile showing what they cite most.
When was Gilead Sciences, Inc. inspected by FDA?
The inspection ran Oct 11 – Oct 18, 2011, and the Form 483 is dated October 18, 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.