Debra M. Emerson
FDA investigator · also recorded as Debra Emerson, Lcdr Debra Emerson
Appears on 27 documents from 2008 to 2022, mostly at sites in Massachusetts. Most often cites control of microbiological contamination (21 CFR 211.113).
- 27
- Documents on file
- 9.5
- Observations per 483
- 2008
- First seen
- 2022
- Most recent
What they cite most
From 157 observations- 21 CFR 211.113Control of microbiological contamination23
- 21 CFR 211.192Production record review21
- 21 CFR 211.42Design and construction features15
- 21 CFR 211.67Equipment cleaning and maintenance15
- 21 CFR 211.100Written procedures; deviations14
- 21 CFR 211.68Automatic, mechanical, and electronic equipment9
Activity by year
2008: 2, 2009: 1, 2010: 2, 2012: 2, 2013: 2, 2014: 1, 2015: 1, 2016: 2, 2017: 2, 2018: 1, 2019: 3, 2020: 1, 2021: 6, 2022: 1
Where
Massachusetts 15 · Maryland 3 · France 2 · Germany 1 · Illinois 1 · New Hampshire 1
Often inspects with
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Inspection history
27 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2022-03-04 | 483 CSL Behring GmbHMar 4, 2022 · Marburg, Germany | Marburg, Germany | 6 | |
| 2021-10-22 | 483 Lonza Houston Inc.Oct 22, 2021 · Portsmouth, New Hampshire | Portsmouth, New Hampshire | 4 | |
| 2021-09-24 | 483 CSL Behring L.L.C.Sep 24, 2021 · Bradley, Illinois | Bradley, Illinois | 9 | |
| 2021-07-23 | 483 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLCJul 23, 2021 · Andover, Massachusetts | Andover, Massachusetts | 13 | |
| 2021-07-23 | EIR Wyeth BioPharma Division of Wyeth Pharmaceuticals LLCJul 23, 2021 · Andover, Massachusetts | Andover, Massachusetts | — | |
| 2021-04-20 | 483 Emergent Manufacturing Operations Baltimore, LLCApr 20, 2021 · Baltimore, Maryland | Baltimore, Maryland | 9 | |
| 2021-04-20 | 483 Emergent Manufacturing Operations Baltimore, LLGApr 20, 2021 · Baltimore, Maryland | Baltimore, Maryland | 9 |
About this profile
What does Debra M. Emerson inspect?
Debra M. Emerson appears on 27 documents on file covering 23 sites, mostly in Massachusetts.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.192 and 21 CFR 211.42.
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 Debra M. Emerson is dated Mar 4, 2022.