Katarzyna Plona
FDA investigator
Appears on 2 documents from 2024, mostly at sites in Connecticut. Most often cites quality audit (21 CFR 820.22).
- 2
- Documents on file
- 5.5
- Observations per 483
- 2024
- First seen
- 2024
- Most recent
What they cite most
From 11 observations- 21 CFR 820.22Quality audit2
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.184Device history record1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.20(c)Management responsibility1
Activity by year
2024: 2
Where
Connecticut 2
Is Katarzyna Plona 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
2 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-08-23 | 483 Kelyniam Global, IncAug 23, 2024 · Collinsville, Connecticut | Collinsville, Connecticut | 5 | |
| 2024-05-22 | 483 Calmare Therapeutics, IncMay 22, 2024 · Shelton, Connecticut | Shelton, Connecticut | 6 |
About this profile
What does Katarzyna Plona inspect?
Katarzyna Plona appears on 2 documents on file covering 2 sites, mostly in Connecticut.
What do they cite most often?
21 CFR 820.22 (quality audit), followed by 21 CFR 803.17 and 21 CFR 820.100(a).
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 Katarzyna Plona is dated Aug 23, 2024.