Falck Medical Incorporated
Form 483 issued August 21, 2023 · Mystic, Connecticut
- Inspection
- Aug 17 – Aug 21, 2023
- Investigator
- Andrew Garufi
- Observations
- 6
- Pages
- 4
- FEI number
- 3003156974
In short: On August 21, 2023, FDA issued a Form 483 with 6 observations to Falck Medical Incorporated in Mystic, Connecticut (FEI 3003156974) after an inspection that ran Aug 17 – Aug 21, 2023. The investigator was Andrew Garufi. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 6 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 03
Procediues for rework of nonconforming product…
- 04
Requirements that must be met by suppliers, contractors and consultants…
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 firmFalck Medical Incorporated history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Falck Medical Incorporated?
FDA listed 6 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Falck Medical Incorporated?
Andrew Garufi is named on this Form 483, for the inspection of Aug 17 – Aug 21, 2023. Each investigator has a profile showing what they cite most.
When was Falck Medical Incorporated inspected by FDA?
The inspection ran Aug 17 – Aug 21, 2023, and the Form 483 is dated August 21, 2023.
How do I get the full Form 483 for Falck Medical Incorporated?
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.