Jacek Cieslak
FDA investigator
Appears on 6 documents from 2019 to 2023, most often at sites in Japan. Most often cites written procedures; deviations (21 CFR 211.100).
- 6
- Documents on file
- 6.3
- Observations per 483
- 2019
- First seen
- 2023
- Most recent
What they cite most
From 38 observations- 21 CFR 211.100Written procedures; deviations7
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.160General requirements3
Activity by year
2019: 1, 2021: 3, 2022: 1, 2023: 1
Where
Japan 2 · Ireland 1 · North Carolina 1 · Poland 1 · Rhode Island 1
Often inspects with
Is Jacek Cieslak coming to your site?
Our team writes custom reports before an inspection: what this investigator cites most, how they write it up, and how your site's history compares, in one brief you can circulate.
Ask about any investigator in Claude or ChatGPT with the AI connector.
Inspection history
6 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-01-24 | 483 Alexion Pharma International Operations LimitedJan 24, 2023 · Dublin, Ireland | Dublin, Ireland | 4 | |
| 2022-03-22 | 483 Polpharma Biologics S.A.Mar 22, 2022 · Gdansk, Poland | Gdansk, Poland | 11 | |
| 2021-12-07 | 483 Immunex Rhode Island CorporationDec 7, 2021 · West Greenwich, Rhode Island | West Greenwich, Rhode Island | 4 | |
| 2021-08-30 | 483 Kyowa Kirin Co., Ltd.Aug 30, 2021 · Takasaki-shi, Japan | Takasaki-shi, Japan | 7 | |
| 2021-04-21 | 483 Fujifilm Diosynth Biotechnologies USA, Inc.Apr 21, 2021 · Morrisville, North Carolina | Morrisville, North Carolina | 10 | |
| 2019-10-07 | 483 Astellas Pharma Inc.Oct 7, 2019 · Toyama, Japan | Toyama, Japan | 2 |
About this profile
What does Jacek Cieslak inspect?
Jacek Cieslak appears on 6 documents on file covering 6 sites, most often in Japan.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.42 and 21 CFR 211.67.
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 Jacek Cieslak is dated Jan 24, 2023.