Genentech, Inc.
Form 483 issued September 2, 2011 · South San Francisco, California
- Inspection
- Sep 2, 2011
- Investigators
- He Nry- K. Lau· Min-Shan-Ma Llu· Peter E. Baker
- Observations
- 4
- Pages
- 4
- FEI number
- 2917293
In short: On September 2, 2011, FDA issued a Form 483 with 4 observations to Genentech, Inc. in South San Francisco, California (FEI 2917293) after an inspection that ran Sep 2, 2011. The investigators were He Nry- K. Lau, Min-Shan-Ma Llu, Peter E. Baker and William V. Millar. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
There was a failure to handle and store closures at all times in a…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
He Nry- K. Lau
1 document · 2011
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 211.192
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 quality system, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Genentech, Inc.?
He Nry- K. Lau, Min-Shan-Ma Llu, Peter E. Baker and William V. Millar are named on this Form 483, for the inspection of Sep 2, 2011. Each investigator has a profile showing what they cite most.
When was Genentech, Inc. inspected by FDA?
The inspection ran Sep 2, 2011, and the Form 483 is dated September 2, 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.