Gunther Bockhoudt
FDA investigator
Appears on 3 documents from 2017 to 2019, most often at sites in Ireland. Most often cites production record review (21 CFR 211.192).
- 3
- Documents on file
- 3.3
- Observations per 483
- 2017
- First seen
- 2019
- Most recent
What they cite most
From 10 observations- 21 CFR 211.192Production record review3
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.22Responsibilities of quality control unit1
Activity by year
2017: 1, 2018: 1, 2019: 1
Where
Ireland 1 · Massachusetts 1 · New Jersey 1
Often inspects with
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-05-03 | 483 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLCMay 3, 2019 · Andover, Massachusetts | Andover, Massachusetts | 3 | |
| 2018-08-14 | 483 Immunomedics, Inc.Aug 14, 2018 · Morris Plains, New Jersey | Morris Plains, New Jersey | 4 | |
| 2017-05-02 | 483 BioMarin International LimitedMay 2, 2017 · Shanbally, Ireland | Shanbally, Ireland | 3 |
About this profile
What does Gunther Bockhoudt inspect?
Gunther Bockhoudt appears on 3 documents on file covering 3 sites, most often in Ireland.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.100 and 21 CFR 211.113.
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 Gunther Bockhoudt is dated May 3, 2019.