Genentech, Inc.
Form 483 issued August 11, 2023 · South San Francisco, California
- Inspection
- Aug 7 – Aug 11, 2023
- Investigator
- Scott N. Lim
- Observations
- 1
- Pages
- 2
- FEI number
- 2917293
In short: On August 11, 2023, FDA issued a Form 483 with 1 observation to Genentech, Inc. in South San Francisco, California (FEI 2917293) after an inspection that ran Aug 7 – Aug 11, 2023. The investigator was Scott N. Lim. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.56 (review of ongoing investigations).
At a glance
1 of 1 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.56(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to notify FDA of the ending, for cause, of an investigator's…
This inspection in context
Scott N. Lim
14 documents · 2019–2026
Cites 211.165(a) (testing and release for distribution) more than any other section. Most of their documents are for sites in California.
The firmGenentech, Inc. history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 312.56(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Genentech, Inc.?
FDA listed 1 observation on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.56 (review of ongoing investigations). The opening words of each observation are shown on this page.
Who inspected Genentech, Inc.?
Scott N. Lim is named on this Form 483, for the inspection of Aug 7 – Aug 11, 2023. Each investigator has a profile showing what they cite most.
When was Genentech, Inc. inspected by FDA?
The inspection ran Aug 7 – Aug 11, 2023, and the Form 483 is dated August 11, 2023.
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.