Genetech, Inc.
Form 483 issued June 22, 2018 · San Diego, California
- Inspection
- Jun 18 – Jun 22, 2018
- Investigator
- Tania Y. Hall
- Observations
- 10
- Pages
- 6
- FEI number
- 3013306140
In short: On June 22, 2018, FDA issued a Form 483 with 10 observations to Genetech, Inc. in San Diego, California (FEI 3013306140) after an inspection that ran Jun 18 – Jun 22, 2018. The investigator was Tania Y. Hall. Most observations concern hCT/P and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by hct/p.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The eligibility of an HCT/P donor was not determined and documented by a responsible person, based…
- 02
Communicable disease agent tests were not FDA-licensed, approved or…
- 03
Procedures for all steps performed in the determining of donor eligibility of HCT/Ps were not established…
- 04
There is no quality…
This inspection in context
Tania Y. Hall
5 documents · 2003–2019
Cites 211.198(a) (complaint files) more than any other section. Most of their documents are for sites in California.
The firmGenetech, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Genetech, Inc.?
FDA listed 10 observations on this Form 483, mostly about hCT/P, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Genetech, Inc.?
Tania Y. Hall is named on this Form 483, for the inspection of Jun 18 – Jun 22, 2018. Each investigator has a profile showing what they cite most.
When was Genetech, Inc. inspected by FDA?
The inspection ran Jun 18 – Jun 22, 2018, and the Form 483 is dated June 22, 2018.
How do I get the full Form 483 for Genetech, 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.