Gilead Sciences, Inc.
Form 483 issued July 22, 2020 · Foster City, California
- Inspection
- Jul 7 – Jul 22, 2020
- Observations
- 2
- Pages
- 4
- FEI number
- 1000523075
In short: On July 22, 2020, FDA issued a Form 483 with 2 observations to Gilead Sciences, Inc. in Foster City, California (FEI 1000523075) after an inspection that ran Jul 7 – Jul 22, 2020. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.58 (inspection of sponsor's records and reports).
At a glance
Observations span 1 system, led by clinical (bimo).
Most cited: 21 CFR 11 (1×) · 21 CFR 312.58(a) (1×)
What FDA observed
Preview: the opening words of each observation- 0121 CFR 11
Electronic records are used, but they do not meet system access limitation requirements to ensure that…
- 0221 CFR 312.58(a)
Failure to permit FDA to have access to and review records or reports related…
This inspection in context
Questions about this 483
What did FDA find at Gilead Sciences, Inc.?
FDA listed 2 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.58 (inspection of sponsor's records and reports). The opening words of each observation are shown on this page.
When was Gilead Sciences, Inc. inspected by FDA?
The inspection ran Jul 7 – Jul 22, 2020, and the Form 483 is dated July 22, 2020.
How do I get the full Form 483 for Gilead Sciences, Inc.?
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