Gilead Sciences, Inc.
Form 483 issued February 12, 2024 · La Verne, California
- Inspection
- Feb 5 – Feb 12, 2024
- Observations
- 1
- Pages
- 3
- FEI number
- 3013189568
In short: On February 12, 2024, FDA issued a Form 483 with 1 observation to Gilead Sciences, Inc. in La Verne, California (FEI 3013189568) after an inspection that ran Feb 5 – Feb 12, 2024. Most observations concern production; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.188 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Batch production and control records do not include the identity of individual major equipment used for…
This inspection in context
Questions about this 483
What did FDA find at Gilead Sciences, Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
When was Gilead Sciences, Inc. inspected by FDA?
The inspection ran Feb 5 – Feb 12, 2024, and the Form 483 is dated February 12, 2024.
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.