Monika Borkowska
FDA investigator
Appears on 6 documents from 2018 to 2022, mostly at sites in New Jersey. Most often cites equipment cleaning and maintenance (21 CFR 211.67).
- 6
- Documents on file
- 4.2
- Observations per 483
- 2018
- First seen
- 2022
- Most recent
What they cite most
From 25 observations- 21 CFR 211.67Equipment cleaning and maintenance6
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products3
- 21 CFR 211.160(b)(1)General requirements2
- 21 CFR 211.188(b)(10)Batch production and control records2
- 21 CFR 211.192Production record review2
- 21 CFR 211.198(a)Complaint files2
Activity by year
2018: 1, 2019: 1, 2020: 1, 2021: 1, 2022: 2
Where
New Jersey 5 · Pennsylvania 1
Often inspects with
Is Monika Borkowska 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 |
|---|---|---|---|---|
| 2022-08-17 | 483 Bentley Laboratories, LLCAug 17, 2022 · Edison, New Jersey | Edison, New Jersey | 3 | |
| 2022-07-08 | 483 KVK-TECH, INC.Jul 8, 2022 · NEWTOWN, Pennsylvania | NEWTOWN, Pennsylvania | 10 | |
| 2021-05-14 | 483 APNAR PHARMA LLPMay 14, 2021 · EAST WINDSOR, New Jersey | EAST WINDSOR, New Jersey | 3 | |
| 2020-10-26 | 483 QUAGEN PHARMACEUTICALS LLCOct 26, 2020 · West Caldwell, New Jersey | West Caldwell, New Jersey | 2 | |
| 2019-03-15 | 483 QUAGEN PHARMACEUTICALS LLCMar 15, 2019 · West Caldwell, New Jersey | West Caldwell, New Jersey | 1 | |
| 2018-12-18 | 483 US Pharmaceuticals IncDec 18, 2018 · Belleville, New Jersey | Belleville, New Jersey | 6 |
About this profile
What does Monika Borkowska inspect?
Monika Borkowska appears on 6 documents on file covering 5 sites, mostly in New Jersey.
What do they cite most often?
21 CFR 211.67 (equipment cleaning and maintenance), followed by 21 CFR 211.110(a) and 21 CFR 211.160(b)(1).
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 Monika Borkowska is dated Aug 17, 2022.