Genentech, Inc.
Form 483 issued February 2, 2023 · South San Francisco, California
- Inspection
- Jan 26 – Feb 2, 2023
- Investigators
- Michael R. Shanks· Nayan J. Patel· Yi Wang
- Observations
- 4
- Pages
- 4
- FEI number
- 2917293
In short: On February 2, 2023, FDA issued a Form 483 with 4 observations to Genentech, Inc. in South San Francisco, California (FEI 2917293) after an inspection that ran Jan 26 – Feb 2, 2023. The investigators were Michael R. Shanks, Nayan J. Patel and Yi Wang. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and materials account for 3 of 4 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm's microbial cross-contamination control in the Glofitamab drug product Filling…
- 02
Your firm’s aseptic processing area for the CPMF (Building™) Glofitamab drug product Vial Filling Line Mis…
- 03
Quality oversight of validation…
- 04
Washing facilities lack hot…
This inspection in context
Michael R. Shanks
27 documents · 2017–2024
Cites 211.113 (control of microbiological contamination) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Genentech, Inc.?
FDA listed 4 observations on this Form 483, mostly about production, materials and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Genentech, Inc.?
Michael R. Shanks, Nayan J. Patel and Yi Wang are named on this Form 483, for the inspection of Jan 26 – Feb 2, 2023. Each investigator has a profile showing what they cite most.
When was Genentech, Inc. inspected by FDA?
The inspection ran Jan 26 – Feb 2, 2023, and the Form 483 is dated February 2, 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.