Maida Henesian
FDA investigator
Appears on 3 documents from 2015 to 2023, mostly at sites in California. Most often cites if I am a manufacturer, what reporting requirements apply to me? (21 CFR 803.50(a)(1)).
- 3
- Documents on file
- 5.7
- Observations per 483
- 2015
- First seen
- 2023
- Most recent
What they cite most
From 17 observations- 21 CFR 803.50(a)(1)If I am a manufacturer, what reporting requirements apply to me?2
- 21 CFR 820.100Corrective and preventive action2
- 21 CFR 820.198Complaint files2
- 21 CFR 820.30Design controls2
- 21 CFR 820.90Nonconforming product2
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
Activity by year
2015: 1, 2020: 1, 2023: 1
Where
California 3
Often inspects with
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-02-10 | 483 Outset Medical, Inc-Feb 10, 2023 · San Jose, California | San Jose, California | 4 | |
| 2020-11-03 | 483 James Consolidated, IncNov 3, 2020 · Concord, California | Concord, California | 10 | |
| 2015-10-22 | 483 Abbott Diabetes Care, IncOct 22, 2015 · Alameda, California | Alameda, California | 3 |
About this profile
What does Maida Henesian inspect?
Maida Henesian appears on 3 documents on file covering 3 sites, mostly in California.
What do they cite most often?
21 CFR 803.50(a)(1) (if I am a manufacturer, what reporting requirements apply to me?), followed by 21 CFR 820.100 and 21 CFR 820.198.
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 Maida Henesian is dated Feb 10, 2023.