Patrick Lynch
FDA investigator
Appears on 2 documents from 2017 to 2018, mostly at sites in Netherlands. Most often cites general requirements (21 CFR 211.160).
- 2
- Documents on file
- 7.0
- Observations per 483
- 2017
- First seen
- 2018
- Most recent
What they cite most
From 14 observations- 21 CFR 211.160General requirements3
- 21 CFR 211.192Production record review2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.142Warehousing procedures1
- 21 CFR 211.182Equipment cleaning and use log1
Activity by year
2017: 1, 2018: 1
Where
Netherlands 1 · South Korea 1
Often inspects with
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Inspection history
2 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2018-02-13 | 483 Patheon Biologics B.V.Feb 13, 2018 · Groningen, Netherlands | Groningen, Netherlands | 10 | |
| 2017-07-25 | 483 Samsung BioLogicsJul 25, 2017 · Yeonsu-gu, South Korea | Yeonsu-gu, South Korea | 4 |
About this profile
What does Patrick Lynch inspect?
Patrick Lynch appears on 2 documents on file covering 2 sites, mostly in Netherlands.
What do they cite most often?
21 CFR 211.160 (general requirements), followed by 21 CFR 211.192 and 21 CFR 211.84.
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 Patrick Lynch is dated Feb 13, 2018.