Form 483 · FEI 3018755991
Form 483 issued February 24, 2025 · Fayetteville, North Carolina
- Inspection
- Feb 24, 2025
- Investigators
- Kritie A. Green· Sonya M. Edmonds
- Observations
- 6
- Pages
- 4
- FEI number
- 3018755991
In short: On February 24, 2025, FDA issued a Form 483 with 6 observations to an FDA-inspected site in Fayetteville, North Carolina (FEI 3018755991) after an inspection that ran Feb 24, 2025. The investigators were Kritie A. Green and Sonya M. Edmonds.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to have systems and processes in place to ensure compliance with the requirements…
This inspection in context
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 6 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Kritie A. Green and Sonya M. Edmonds are named on this Form 483, for the inspection of Feb 24, 2025. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Feb 24, 2025, and the Form 483 is dated February 24, 2025.
How do I get the full Form 483 for an FDA-inspected site?
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.