Reflexonic, LLC
Form 483 issued April 19, 2016 · Frederick, Maryland
- Inspection
- Apr 4 – Apr 19, 2016
- Investigator
- James Michael Simpson
- Observations
- 9
- Pages
- 6
- FEI number
- 3009129589
In short: On April 19, 2016, FDA issued a Form 483 with 9 observations to Reflexonic, LLC in Frederick, Maryland (FEI 3009129589) after an inspection that ran Apr 4 – Apr 19, 2016. The investigator was James Michael Simpson. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and design controls account for 7 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design validation have…
- 02
Design verification does not confirm that design output…
- 03
Procedures for design input have…
- 04
Procedures for corrective and preventive action have not been…
This inspection in context
James Michael Simpson
7 documents · 2015–2018
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in Virginia.
The firmReflexonic, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Reflexonic, LLC?
FDA listed 9 observations on this Form 483, mostly about cAPA, design controls and production & process 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 Reflexonic, LLC?
James Michael Simpson is named on this Form 483, for the inspection of Apr 4 – Apr 19, 2016. Each investigator has a profile showing what they cite most.
When was Reflexonic, LLC inspected by FDA?
The inspection ran Apr 4 – Apr 19, 2016, and the Form 483 is dated April 19, 2016.
How do I get the full Form 483 for Reflexonic, 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.