Kathleen M. Jordan
FDA investigator · also recorded as Ko Kathleen M. Jordan, Ran Kathleen M. Jordan
Appears on 6 documents from 2021 to 2023, mostly at sites in Maryland. Most often cites production record review (21 CFR 211.192).
- 6
- Documents on file
- 4.2
- Observations per 483
- 2021
- First seen
- 2023
- Most recent
What they cite most
From 38 observations- 21 CFR 211.192Production record review7
- 21 CFR 211.68Automatic, mechanical, and electronic equipment6
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.67Equipment cleaning and maintenance3
Activity by year
2021: 4, 2022: 1, 2023: 1
Where
Maryland 5 · New Jersey 1
Often inspects with
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Inspection history
6 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-01-27 | 483 Modavar PharmaceuticalsJan 27, 2023 · Frederick, Maryland | Frederick, Maryland | 8 | |
| 2022-08-25 | 483 Form 483 · FEI 3002889358Aug 25, 2022 · Branchburg, New Jersey | Branchburg, New Jersey | 2 | |
| 2021-12-02 | 483 Valgene Incorporated dba Cape DrugsDec 2, 2021 · Annapolis, Maryland | Annapolis, Maryland | 4 | |
| 2021-09-29 | 483 Pharmaceutics International, Inc.Sep 29, 2021 · Cockeysville, Maryland | Cockeysville, Maryland | 3 | |
| 2021-09-29 | 483 Pharmaceutics International, Inc.Sep 29, 2021 · Hunt Valley, Maryland | Hunt Valley, Maryland | — | |
| 2021-04-16 | 483 Bora Pharmaceuticals Injectables Inc.Apr 16, 2021 · Baltimore, Maryland | Baltimore, Maryland | 4 |
About this profile
What does Kathleen M. Jordan inspect?
Kathleen M. Jordan appears on 6 documents on file covering 6 sites, mostly in Maryland.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.68 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 Kathleen M. Jordan is dated Jan 27, 2023.