Suzanne M. Healy
FDA investigator
Appears on 5 documents from 2017 to 2023, most often at sites in Massachusetts. Most often cites design controls (21 CFR 820.30(g)).
- 5
- Documents on file
- 3.8
- Observations per 483
- 2017
- First seen
- 2023
- Most recent
What they cite most
From 19 observations- 21 CFR 820.30(g)Design controls5
- 21 CFR 820.100(a)Corrective and preventive action3
- 21 CFR 803.50(a)(1)If I am a manufacturer, what reporting requirements apply to me?2
- 21 CFR 820.198(a)Complaint files2
- 21 CFR 820.90(a)Nonconforming product2
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
Activity by year
2017: 2, 2019: 1, 2023: 2
Where
Massachusetts 2 · California 1 · Florida 1 · Pennsylvania 1
Often inspects with
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Inspection history
5 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-09-20 | 483 Sun Dental Laboratories, LLCSep 20, 2023 · Saint Petersburg, Florida | Saint Petersburg, Florida | 3 | |
| 2023-02-10 | 483 Outset Medical, Inc-Feb 10, 2023 · San Jose, California | San Jose, California | 4 | |
| 2019-02-14 | 483 PhytogenX, Inc.Feb 14, 2019 · Morgantown, Pennsylvania | Morgantown, Pennsylvania | 1 | |
| 2017-06-29 | 483 Magellan Diagnostics, Inc.Jun 29, 2017 · North Billerica, Massachusetts | North Billerica, Massachusetts | 9 | |
| 2017-04-04 | 483 Nova Biomedical CorporationApr 4, 2017 · Waltham, Massachusetts | Waltham, Massachusetts | 2 |
About this profile
What does Suzanne M. Healy inspect?
Suzanne M. Healy appears on 5 documents on file covering 4 sites, most often in Massachusetts.
What do they cite most often?
21 CFR 820.30(g) (design controls), followed by 21 CFR 820.100(a) and 21 CFR 803.50(a)(1).
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 Suzanne M. Healy is dated Sep 20, 2023.