Onus Bm
FDA investigator
Appears on 1 document from 2019, mostly at sites in California. Most often cites production record review (21 CFR 211.192).
- 1
- Documents on file
- 12.0
- Observations per 483
- 2019
- First seen
- 2019
- Most recent
What they cite most
From 12 observations- 21 CFR 211.192Production record review3
- 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 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
Activity by year
2019: 1
Where
California 1
Often inspects with
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Inspection history
1 document, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-09-12 | 483 Grifols Biologicals LLCSep 12, 2019 · Los Angeles, California | Los Angeles, California | 12 |
About this profile
What does Onus Bm inspect?
Onus Bm appears on 1 document on file covering 1 site, mostly in California.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.100 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 Onus Bm is dated Sep 12, 2019.