Form 483 · FEI 3014833750
Form 483 issued June 14, 2024 · Durham, North Carolina
- Inspection
- Jun 4 – Jun 14, 2024
- Investigator
- Inga M. Warr
- Observations
- 7
- Pages
- 8
- FEI number
- 3014833750
In short: On June 14, 2024, FDA issued a Form 483 with 7 observations to an FDA-inspected site in Durham, North Carolina (FEI 3014833750) after an inspection that ran Jun 4 – Jun 14, 2024. The investigator was Inga M. Warr. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures have not been adequately established to control product that does not…
- 02
A device history record has…
- 03
Labeling was not sufficiently examined by a designated individual for accuracy including unique device identifier (UDI)…
- 04
Design verification does not confirm that design output…
This inspection in context
Inga M. Warr
4 documents · 2024–2025
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Tennessee.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.90(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 7 observations on this Form 483, mostly about production & process controls, cAPA and records & documents. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Inga M. Warr is named on this Form 483, for the inspection of Jun 4 – Jun 14, 2024. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jun 4 – Jun 14, 2024, and the Form 483 is dated June 14, 2024.
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.