Genetech, Inc.
FDA inspection history in San Diego, California, 2018
- 1
- Close-out
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2018: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One close-out letter and one Form 483, at San Diego, California.
Cited most
Across all Genetech observations on file
- 21 CFR 211.42Design and construction features2
- 21 CFR 1271.47What procedures must I establish and maintain?1
- 21 CFR 1271.50How do I determine whether a donor is eligible?1
- 21 CFR 1271.80What are the general requirements for donor testing?1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
The complete Genetech file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
San Diego, California
One close-out letter and one Form 483 · 2018 · 10 observations
Latest: Close-out, Nov 29, 2018 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-11-29 | Close-out Close-out letter | San Diego, California | — | $99 |
| 2018-06-22 | 483 Form 483 | San Diego, California | 10 | $99 |
Investigators on these documents
FEI number 3013306140 · most recent document Nov 29, 2018
About Genetech, Inc.
How many FDA Form 483s has Genetech, Inc. received?
FDA Intel has 1 Form 483 on file for Genetech, Inc.; the most recent is dated Jun 22, 2018.
When was Genetech, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Genetech, Inc. is a Form 483 dated Jun 22, 2018, for the site in San Diego, California.
What did FDA cite at Genetech, Inc.?
The regulations cited most in the observations on file for Genetech, Inc. are 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 1271.47 (What procedures must I establish and maintain?), 1 time; 21 CFR 1271.50 (How do I determine whether a donor is eligible?), 1 time.