Genentech, Inc.
Form 483 issued July 8, 2016 · South San Francisco, California
- Inspection
- Jun 20 – Jul 8, 2016
- Investigators
- Anh Lac· Rebecca Rodriguez· Stephanie A. Slater
- Observations
- 2
- Pages
- 3
- FEI number
- 2917293
In short: On July 8, 2016, FDA issued a Form 483 with 2 observations to Genentech, Inc. in South San Francisco, California (FEI 2917293) after an inspection that ran Jun 20 – Jul 8, 2016. The investigators were Anh Lac, Rebecca Rodriguez and Stephanie A. Slater. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(a) (1×) · 211.180(e) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks authority to fully investigate…
- 02
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
This inspection in context
Anh Lac
13 documents · 2012–2017
Cites 211.42 (design and construction features) 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 211.22(a)
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 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.?
Anh Lac, Rebecca Rodriguez and Stephanie A. Slater are named on this Form 483, for the inspection of Jun 20 – Jul 8, 2016. Each investigator has a profile showing what they cite most.
When was Genentech, Inc. inspected by FDA?
The inspection ran Jun 20 – Jul 8, 2016, and the Form 483 is dated July 8, 2016.
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.