Genentech, Inc.
Form 483 issued October 18, 2017 · Oceanside, California
- Inspection
- Oct 10 – Oct 18, 2017
- Investigators
- Ashar P. Parikh· Linda Thai
- Observations
- 2
- Pages
- 2
- FEI number
- 3006129086
In short: On October 18, 2017, FDA issued a Form 483 with 2 observations to Genentech, Inc. in Oceanside, California (FEI 3006129086) after an inspection that ran Oct 10 – Oct 18, 2017. The investigators were Ashar P. Parikh and Linda Thai. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
During the walk through of your facility, we…
- 02
During our review of Tracking Actions within the Supplier Quality Management group, we observed 30 out…
This inspection in context
Ashar P. Parikh
19 documents · 2014–2026
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
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.58
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Genentech, Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Genentech, Inc.?
Ashar P. Parikh and Linda Thai are named on this Form 483, for the inspection of Oct 10 – Oct 18, 2017. Each investigator has a profile showing what they cite most.
When was Genentech, Inc. inspected by FDA?
The inspection ran Oct 10 – Oct 18, 2017, and the Form 483 is dated October 18, 2017.
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.