Jose O. Hernandez-Guzman
FDA investigator
Appears on 2 documents from 2017 to 2018, mostly at sites in Israel. Most often cites control of microbiological contamination (21 CFR 211.113).
- 2
- Documents on file
- 4.0
- Observations per 483
- 2017
- First seen
- 2018
- Most recent
What they cite most
From 8 observations- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.42Design and construction features1
Activity by year
2017: 1, 2018: 1
Where
Israel 1 · New Jersey 1
Often inspects with
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Inspection history
2 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2018-03-09 | 483 ImClone Systems LLCMar 9, 2018 · Branchburg, New Jersey | Branchburg, New Jersey | 2 | |
| 2017-11-13 | 483 Rafa Laboratories Ltd.Nov 13, 2017 · Jerusalem, Israel | Jerusalem, Israel | 6 |
About this profile
What does Jose O. Hernandez-Guzman inspect?
Jose O. Hernandez-Guzman appears on 2 documents on file covering 2 sites, mostly in Israel.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.100 and 21 CFR 211.165.
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Jose O. Hernandez-Guzman is dated Mar 9, 2018.