Panoramic Rental Corp
Form 483 issued September 7, 2016 · Fort Wayne, Indiana
- Inspection
- Sep 7, 2016
- Investigator
- Amy S. Graf
- Observations
- 5
- Pages
- 5
- FEI number
- 1832462
In short: On September 7, 2016, FDA issued a Form 483 with 5 observations to Panoramic Rental Corp in Fort Wayne, Indiana (FEI 1832462) after an inspection that ran Sep 7, 2016. The investigator was Amy S. Graf. Most observations concern cAPA and design controls.
At a glance
CAPA and design controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Procedures for design change have…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately…
- 04
Requirements that must be met by suppliers, contractors and consultants…
This inspection in context
Amy S. Graf
3 documents · 2016–2019
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Michigan.
The firmPanoramic Rental Corp history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Panoramic Rental Corp?
FDA listed 5 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The opening words of each observation are shown on this page.
Who inspected Panoramic Rental Corp?
Amy S. Graf is named on this Form 483, for the inspection of Sep 7, 2016. Each investigator has a profile showing what they cite most.
When was Panoramic Rental Corp inspected by FDA?
The inspection ran Sep 7, 2016, and the Form 483 is dated September 7, 2016.
How do I get the full Form 483 for Panoramic Rental Corp?
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.