Amy Devlin
FDA investigator
Appears on 4 documents from 2019 to 2020, most often at sites in Illinois. Most often cites written procedures; deviations (21 CFR 211.100).
- 4
- Documents on file
- 3.7
- Observations per 483
- 2019
- First seen
- 2020
- Most recent
What they cite most
From 13 observations- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.192Production record review2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.160General requirements1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.25Personnel qualifications1
Activity by year
2019: 3, 2020: 1
Where
Illinois 1 · Maryland 1 · Massachusetts 1 · North Carolina 1
Often inspects with
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2020-01-29 | 483 Human Genome Sciences, Inc.Jan 29, 2020 · Rockville, Maryland | Rockville, Maryland | 3 | |
| 2019-06-25 | 483 Woodstock Sterile Solutions, Inc.Jun 25, 2019 · Woodstock, Illinois | Woodstock, Illinois | 5 | |
| 2019-05-03 | 483 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLCMay 3, 2019 · Andover, Massachusetts | Andover, Massachusetts | 3 | |
| 2019-03-01 | 483 FUJIFILM Diosynth Biotechnologies U.S.A., IncMar 1, 2019 · Morrisville, North Carolina | Morrisville, North Carolina | — |
About this profile
What does Amy Devlin inspect?
Amy Devlin appears on 4 documents on file covering 4 sites, most often in Illinois.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.192 and 21 CFR 211.110.
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 Devlin is dated Jan 29, 2020.