Retivue Lie
Form 483 issued April 17, 2024 · Charlottesville, Virginia
- Inspection
- Apr 8 – Apr 17, 2024
- Investigator
- Heath A. Gerber
- Observations
- 5
- Pages
- 5
- FEI number
- 3019541696
In short: On April 17, 2024, FDA issued a Form 483 with 5 observations to Retivue Lie in Charlottesville, Virginia (FEI 3019541696) after an inspection that ran Apr 8 – Apr 17, 2024. The investigator was Heath A. Gerber. Most observations concern management controls and production & process controls.
At a glance
Management controls and production & process controls account for 4 of 5 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
Quality audits have not…
- 03
Procedures for collective and preventive action have…
- 04
The evaluation of potential suppliers and…
This inspection in context
Heath A. Gerber
1 document · 2024
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Virginia.
The firmRetivue Lie 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 Retivue Lie?
FDA listed 5 observations on this Form 483, mostly about management controls, production & process controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Retivue Lie?
Heath A. Gerber is named on this Form 483, for the inspection of Apr 8 – Apr 17, 2024. Each investigator has a profile showing what they cite most.
When was Retivue Lie inspected by FDA?
The inspection ran Apr 8 – Apr 17, 2024, and the Form 483 is dated April 17, 2024.
How do I get the full Form 483 for Retivue Lie?
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.