Accord Media, LLC
Form 483 issued June 26, 2017 · New York, New York
- Inspection
- Jun 21 – Jun 26, 2017
- Investigators
- Andrew Garufi· Ashley Polizzotto
- Observations
- 4
- Pages
- 3
- FEI number
- 3011053331
In short: On June 26, 2017, FDA issued a Form 483 with 4 observations to Accord Media, LLC in New York, New York (FEI 3011053331) after an inspection that ran Jun 21 – Jun 26, 2017. The investigators were Andrew Garufi and Ashley Polizzotto. Most observations concern production & process controls and records & documents.
At a glance
3 of 4 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for finished device acceptance have…
- 02
The evaluation of potential…
- 03
Although a control number is required for this type of device, the device does not carry…
- 04
A device master 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 firmAccord Media, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.80(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Accord Media, LLC?
FDA listed 4 observations on this Form 483, mostly about production & process controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Accord Media, LLC?
Andrew Garufi and Ashley Polizzotto are named on this Form 483, for the inspection of Jun 21 – Jun 26, 2017. Each investigator has a profile showing what they cite most.
When was Accord Media, LLC inspected by FDA?
The inspection ran Jun 21 – Jun 26, 2017, and the Form 483 is dated June 26, 2017.
How do I get the full Form 483 for Accord Media, LLC?
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.