Genentech, Inc.
Form 483 issued June 23, 2011 · South San Francisco, California
- Inspection
- Jun 14 – Jun 23, 2011
- Investigators
- Carl Lee· Lance M. De Souza· Peter E. Baker
- Observations
- 6
- Pages
- 3
- FEI number
- 2917293
In short: On June 23, 2011, FDA issued a Form 483 with 6 observations to Genentech, Inc. in South San Francisco, California (FEI 2917293) after an inspection that ran Jun 14 – Jun 23, 2011. The investigators were Carl Lee, Lance M. De Souza and Peter E. Baker. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 04
Written records are not always made of…
This inspection in context
Carl Lee
2 documents · 2011–2013
Cites 211.160 (general requirements) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Genentech, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Genentech, Inc.?
Carl Lee, Lance M. De Souza and Peter E. Baker are named on this Form 483, for the inspection of Jun 14 – Jun 23, 2011. Each investigator has a profile showing what they cite most.
When was Genentech, Inc. inspected by FDA?
The inspection ran Jun 14 – Jun 23, 2011, and the Form 483 is dated June 23, 2011.
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.