Karen A. Spencer
FDA investigator
Appears on 3 documents from 2017 to 2022, mostly at sites in Maryland. Most often cites general requirements (21 CFR 211.160).
- 3
- Documents on file
- 16.0
- Observations per 483
- 2017
- First seen
- 2022
- Most recent
What they cite most
From 16 observations- 21 CFR 211.160General requirements2
- 21 CFR 211.194Laboratory records2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 111.105What must quality control personnel do?1
- 21 CFR 111.113What quality control operations are required for a material review and disposition decision?1
- 21 CFR 111.123What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?1
Activity by year
2017: 1, 2022: 2
Where
Maryland 2 · New Jersey 1
Often inspects with
Is Karen A. Spencer 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
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2022-03-23 | EIR Cava Foods LLCMar 23, 2022 · Laurel, Maryland | Laurel, Maryland | — | |
| 2022-02-03 | 483 Aspire Pharmaceuticals Inc.Feb 3, 2022 · Somerset, New Jersey | Somerset, New Jersey | 16 | |
| 2017-03-24 | EIR Cava Foods LLCMar 24, 2017 · Laurel, Maryland | Laurel, Maryland | — |
About this profile
What does Karen A. Spencer inspect?
Karen A. Spencer appears on 3 documents on file covering 2 sites, mostly in Maryland.
What do they cite most often?
21 CFR 211.160 (general requirements), followed by 21 CFR 211.194 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 Karen A. Spencer is dated Mar 23, 2022.