Gilead Sciences, Inc.
Form 483 issued July 17, 2018 · Foster City, California
- Inspection
- Jul 9 – Jul 17, 2018
- Observations
- 1
- Pages
- 3
- FEI number
- 1000523075
In short: On July 17, 2018, FDA issued a Form 483 with 1 observation to Gilead Sciences, Inc. in Foster City, California (FEI 1000523075) after an inspection that ran Jul 9 – Jul 17, 2018. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observation- 01
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA…
This inspection in context
Questions about this 483
What did FDA find at Gilead Sciences, Inc.?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
When was Gilead Sciences, Inc. inspected by FDA?
The inspection ran Jul 9 – Jul 17, 2018, and the Form 483 is dated July 17, 2018.
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.