Andrew Garufi
FDA investigator
Appears on 11 documents from 2015 to 2025, mostly at sites in New York. Most often cites receiving, in-process, and finished device acceptance (21 CFR 820.80(b)).
- 11
- Documents on file
- 3.8
- Observations per 483
- 2015
- First seen
- 2025
- Most recent
What they cite most
From 42 observations- 21 CFR 820.80(b)Receiving, in-process, and finished device acceptance6
- 21 CFR 820.50(a)Purchasing controls5
- 21 CFR 820.198(a)Complaint files4
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?3
- 21 CFR 820.100(a)Corrective and preventive action3
- 21 CFR 820.22Quality audit3
Activity by year
2015: 2, 2016: 1, 2017: 1, 2018: 2, 2021: 1, 2023: 2, 2024: 1, 2025: 1
Where
New York 10 · Connecticut 1
Often inspects with
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Inspection history
11 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-10-20 | 483 WS Audiology USA Inc.Oct 20, 2025 · Hauppauge, New York | Hauppauge, New York | 1 | |
| 2024-04-17 | 483 Prove Labs IncApr 17, 2024 · Brooklyn, New York | Brooklyn, New York | 6 | |
| 2023-09-12 | 483 Banyan USA LLCSep 12, 2023 · Hauppauge, New York | Hauppauge, New York | 9 | |
| 2023-08-21 | 483 Falck Medical IncorporatedAug 21, 2023 · Mystic, Connecticut | Mystic, Connecticut | 6 | |
| 2021-05-20 | 483 Aerolase Corp.May 20, 2021 · Tarrytown, New York | Tarrytown, New York | 2 | |
| 2018-07-18 | 483 Accurate Surgical & ScientificJul 18, 2018 · Westbury, New York | Westbury, New York | 1 | |
| 2018-03-29 | 483 Advanced Monitored CaregivingMar 29, 2018 · New York, New York | New York, New York | 4 |
About this profile
What does Andrew Garufi inspect?
Andrew Garufi appears on 11 documents on file covering 11 sites, mostly in New York.
What do they cite most often?
21 CFR 820.80(b) (receiving, in-process, and finished device acceptance), followed by 21 CFR 820.50(a) and 21 CFR 820.198(a).
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 Andrew Garufi is dated Oct 20, 2025.