Prestige Medical
Form 483 issued October 24, 2019 · Northridge, California
- Inspection
- Oct 23 – Oct 24, 2019
- Investigator
- Kelvin Cheung
- Observations
- 4
- Pages
- 3
- FEI number
- 2081040
In short: On October 24, 2019, FDA issued a Form 483 with 4 observations to Prestige Medical in Northridge, California (FEI 2081040) after an inspection that ran Oct 23 – Oct 24, 2019. The investigator was Kelvin Cheung. Most observations concern production & process controls and management controls.
At a glance
Production & process controls and management controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Management with executive responsibility has not reviewed the suitability and effectiveness of the quality…
- 02
Not all complaints have been adequately reviewed and evaluated to determine whether…
- 03
Records of acceptable suppliers have…
- 04
The acceptance status of product was not identified to indicate conformance or…
This inspection in context
Kelvin Cheung
5 documents · 2008–2021
Cites 820.100(b) (corrective and preventive action) more than any other section. Most of their documents are for sites in California.
The firmPrestige Medical history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Prestige Medical?
FDA listed 4 observations on this Form 483, mostly about production & process controls, management controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Prestige Medical?
Kelvin Cheung is named on this Form 483, for the inspection of Oct 23 – Oct 24, 2019. Each investigator has a profile showing what they cite most.
When was Prestige Medical inspected by FDA?
The inspection ran Oct 23 – Oct 24, 2019, and the Form 483 is dated October 24, 2019.
How do I get the full Form 483 for Prestige Medical?
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.