Powers Medical Devices, LLC
Form 483 issued September 8, 2016 · Boca Raton, Florida
- Inspection
- Aug 31 – Sep 8, 2016
- Investigator
- Karen M. Rodriguez
- Observations
- 6
- Pages
- 5
- FEI number
- 3009199231
In short: On September 8, 2016, FDA issued a Form 483 with 6 observations to Powers Medical Devices, LLC in Boca Raton, Florida (FEI 3009199231) after an inspection that ran Aug 31 – Sep 8, 2016. The investigator was Karen M. Rodriguez. Most observations concern cAPA and management controls.
At a glance
CAPA and management controls account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 02
Quality audits have not…
- 03
A justification for not reporting the correction or removal action to FDA that included conclusions, follow-ups…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Karen M. Rodriguez
8 documents · 2015–2022
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Florida.
The firmPowers Medical Devices, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Powers Medical Devices, LLC?
FDA listed 6 observations on this Form 483, mostly about cAPA, management controls and production & process controls. The opening words of each observation are shown on this page.
Who inspected Powers Medical Devices, LLC?
Karen M. Rodriguez is named on this Form 483, for the inspection of Aug 31 – Sep 8, 2016. Each investigator has a profile showing what they cite most.
When was Powers Medical Devices, LLC inspected by FDA?
The inspection ran Aug 31 – Sep 8, 2016, and the Form 483 is dated September 8, 2016.
How do I get the full Form 483 for Powers Medical Devices, 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.