Genentech, Inc.
Form 483 issued May 2, 2024 · South San Francisco, California
- Inspection
- Apr 22 – May 2, 2024
- Investigators
- Dustin R. Abaonza· Sheilyn H. Huang
- Observations
- 1
- Pages
- 2
- FEI number
- 2917293
In short: On May 2, 2024, FDA issued a Form 483 with 1 observation to Genentech, Inc. in South San Francisco, California (FEI 2917293) after an inspection that ran Apr 22 – May 2, 2024. The investigators were Dustin R. Abaonza and Sheilyn H. Huang.
What FDA observed
Preview: the opening words of each observation- 01FDCA 505-1(f)(4)
An application holder did not maintain a Support / Call Center or a REMS Program website…
This inspection in context
Dustin R. Abaonza
1 document · 2024
Cites FDCA 505-1(f)(4) 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.
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Questions about this 483
What did FDA find at Genentech, Inc.?
FDA listed 1 observation on this Form 483. The opening words of each observation are shown on this page.
Who inspected Genentech, Inc.?
Dustin R. Abaonza and Sheilyn H. Huang are named on this Form 483, for the inspection of Apr 22 – May 2, 2024. Each investigator has a profile showing what they cite most.
When was Genentech, Inc. inspected by FDA?
The inspection ran Apr 22 – May 2, 2024, and the Form 483 is dated May 2, 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.