Quide! Corporation
Form 483 issued April 10, 2017 · San Diego, California
- Inspection
- Mar 29 – Apr 10, 2017
- Observations
- 4
- Pages
- 2
- FEI number
- 2024674
In short: On April 10, 2017, FDA issued a Form 483 with 4 observations to Quide! Corporation in San Diego, California (FEI 2024674) after an inspection that ran Mar 29 – Apr 10, 2017. 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 observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Production processes were not controlled to ensure that a device…
- 02
Procedures to ensure all purchased or otherwise received product and services conform to specified requirements have…
- 03
Procedures for acceptance activities have…
- 04
Documents that were not approved were observed at a location where…
This inspection in context
Questions about this 483
What did FDA find at Quide! Corporation?
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.
When was Quide! Corporation inspected by FDA?
The inspection ran Mar 29 – Apr 10, 2017, and the Form 483 is dated April 10, 2017.
How do I get the full Form 483 for Quide! Corporation?
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.