Prove Labs Inc.
Form 483 issued April 17, 2024 · Brooklyn, New York
- Inspection
- Apr 9 – Apr 17, 2024
- Investigator
- Andrew Garufi
- Observations
- 6
- Pages
- 4
- FEI number
- 3025488663
In short: On April 17, 2024, FDA issued a Form 483 with 6 observations to Prove Labs Inc. in Brooklyn, New York (FEI 3025488663) after an inspection that ran Apr 9 – Apr 17, 2024. The investigator was Andrew Garufi. Most observations concern cAPA and management controls.
At a glance
CAPA and management controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design change have…
- 02
Written MDR procediues have…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 0421 CFR 801.50(a)
The stand-alone software that is regulated as a medical device did not provide its unique device…
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 firmProve Labs Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Prove Labs Inc.?
FDA listed 6 observations on this Form 483, mostly about cAPA, management controls and design controls. The opening words of each observation are shown on this page.
Who inspected Prove Labs Inc.?
Andrew Garufi is named on this Form 483, for the inspection of Apr 9 – Apr 17, 2024. Each investigator has a profile showing what they cite most.
When was Prove Labs Inc. inspected by FDA?
The inspection ran Apr 9 – Apr 17, 2024, and the Form 483 is dated April 17, 2024.
How do I get the full Form 483 for Prove Labs Inc.?
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.