Amy N. Chen
FDA investigator
Appears on 8 documents from 2022 to 2023, most often at sites in Maryland. Most often cites insanitary conditions (FDCA 501(a)(2)(A)).
- 8
- Documents on file
- 4.9
- Observations per 483
- 2022
- First seen
- 2023
- Most recent
What they cite most
From 39 observations- FDCA 501(a)(2)(A)Insanitary conditions7
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.67Equipment cleaning and maintenance5
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures5
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.100(a)Written procedures; deviations2
Activity by year
2022: 2, 2023: 6
Where
Maryland 3 · New Jersey 2 · Pennsylvania 2 · Virginia 1
Often inspects with
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Inspection history
8 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-12-18 | 483 Aerosol and Liquid Packaging, Inc. 370la Southwestern Blvd Ste 100Dec 18, 2023 · Baltimore, Maryland | Baltimore, Maryland | 1 | |
| 2023-12-18 | 483 Aerosol and Liquid Packaging, Inc.Dec 18, 2023 · Baltimore, Maryland | Baltimore, Maryland | 10 | |
| 2023-09-27 | 483 Piramal Critical Care IncSep 27, 2023 · Bethlehem, Pennsylvania | Bethlehem, Pennsylvania | 2 | |
| 2023-04-06 | 483 Afton Scientific, LLCApr 6, 2023 · Charlottesville, Virginia | Charlottesville, Virginia | 3 | |
| 2023-02-15 | 483 Veranova, L.P.Feb 15, 2023 · West Deptford, New Jersey | West Deptford, New Jersey | 2 | |
| 2023-01-27 | 483 Modavar PharmaceuticalsJan 27, 2023 · Frederick, Maryland | Frederick, Maryland | 8 | |
| 2022-08-05 | 483 Imp rimisRx NJAug 5, 2022 · Ledgewood, New Jersey | Ledgewood, New Jersey | 9 |
About this profile
What does Amy N. Chen inspect?
Amy N. Chen appears on 8 documents on file covering 7 sites, most often in Maryland.
What do they cite most often?
FDCA 501(a)(2)(A) (insanitary conditions), followed by 21 CFR 211.113 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 Amy N. Chen is dated Dec 18, 2023.