Accord Media, LLC
Form 483 issued September 2, 2016 · New York, New York
- Inspection
- Aug 18 – Sep 2, 2016
- Investigator
- Kwong P. Lee
- Observations
- 8
- Pages
- 4
- FEI number
- 3011053331
In short: On September 2, 2016, FDA issued a Form 483 with 8 observations to Accord Media, LLC in New York, New York (FEI 3011053331) after an inspection that ran Aug 18 – Sep 2, 2016. The investigator was Kwong P. Lee. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and production & process controls account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 03
Procedures for corrective and preventive action…
- 04
Procedures for finished device acceptance have…
This inspection in context
Kwong P. Lee
12 documents · 2015–2026
Cites 820.30(c) (design controls) 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 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Accord Media, LLC?
FDA listed 8 observations on this Form 483, mostly about cAPA, production & process controls and design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Accord Media, LLC?
Kwong P. Lee is named on this Form 483, for the inspection of Aug 18 – Sep 2, 2016. Each investigator has a profile showing what they cite most.
When was Accord Media, LLC inspected by FDA?
The inspection ran Aug 18 – Sep 2, 2016, and the Form 483 is dated September 2, 2016.
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.