Aerolase Corp.
Form 483 issued May 20, 2021 · Tarrytown, New York
- Inspection
- May 11 – May 20, 2021
- Investigator
- Andrew Garufi
- Observations
- 2
- Pages
- 4
- FEI number
- 3004374705
In short: On May 20, 2021, FDA issued a Form 483 with 2 observations to Aerolase Corp. in Tarrytown, New York (FEI 3004374705) after an inspection that ran May 11 – May 20, 2021. The investigator was Andrew Garufi. Most observations concern records & documents; the most-cited regulation is 21 CFR 1005.3 (importation of noncomplying goods prohibited).
At a glance
Observations span 1 system, led by records & documents.
Most cited: 21 CFR 1005.3 (1×) · 820.184 (1×)
What FDA observed
Preview: the opening words of each observation- 0121 CFR 1005.3
Electronic products lack proper certification in the form of…
- 02
A device history record has…
This inspection in context
Andrew Garufi
11 documents · 2015–2025
Cites 820.80(b) (receiving, in-process, and finished device acceptance) more than any other section. Most of their documents are for sites in New York.
The firmAerolase Corp. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.184
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aerolase Corp.?
FDA listed 2 observations on this Form 483, mostly about records & documents. The most-cited regulation is 21 CFR 1005.3 (importation of noncomplying goods prohibited). The opening words of each observation are shown on this page.
Who inspected Aerolase Corp.?
Andrew Garufi is named on this Form 483, for the inspection of May 11 – May 20, 2021. Each investigator has a profile showing what they cite most.
When was Aerolase Corp. inspected by FDA?
The inspection ran May 11 – May 20, 2021, and the Form 483 is dated May 20, 2021.
How do I get the full Form 483 for Aerolase Corp.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.