Genentech, Inc.
Form 483 issued March 12, 2024 · South San Francisco, California
- Inspection
- Mar 4 – Mar 12, 2024
- Observations
- 3
- Pages
- 3
- FEI number
- 2917293
In short: On March 12, 2024, FDA issued a Form 483 with 3 observations to Genentech, Inc. in South San Francisco, California (FEI 2917293) after an inspection that ran Mar 4 – Mar 12, 2024. Most observations concern clinical (BIMO).
At a glance
3 of 3 observations on this 483 concern clinical (bimo).
What FDA observed
Preview: the opening words of each observation- 01
Lack of records covering receipt and disposition…
- 02
Failure to ensure proper monitoring of the study and ensure the study is conducted in accordance…
- 03
Failure to provide all participating investigators with an adequate…
This inspection in context
Questions about this 483
What did FDA find at Genentech, Inc.?
FDA listed 3 observations on this Form 483, mostly about clinical (BIMO). The opening words of each observation are shown on this page.
When was Genentech, Inc. inspected by FDA?
The inspection ran Mar 4 – Mar 12, 2024, and the Form 483 is dated March 12, 2024.
How do I get the full Form 483 for Genentech, 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.