Brian M. Janelsins
FDA investigator · also recorded as Yet Aterg Brian Janelsins, Ne Brian Janelsins
Appears on 2 documents from 2023, mostly at sites in Maryland. Most often cites written procedures; deviations (21 CFR 211.100).
- 2
- Documents on file
- 6.0
- Observations per 483
- 2023
- First seen
- 2023
- Most recent
What they cite most
From 6 observations- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.192Production record review1
- 21 CFR 211.25Personnel qualifications1
Activity by year
2023: 2
Where
Maryland 1 · Washington 1
Often inspects with
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Inspection history
2 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-12-11 | 483 Human Genome Sciences, Inc.Dec 11, 2023 · Rockville, Maryland | Rockville, Maryland | 6 | |
| 2023-02-10 | EIR AGC BiologicsFeb 10, 2023 · Bothell, Washington | Bothell, Washington | — |
About this profile
What does Brian M. Janelsins inspect?
Brian M. Janelsins appears on 2 documents on file covering 2 sites, mostly in Maryland.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.110 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 Brian M. Janelsins is dated Dec 11, 2023.