Simpex Medical Inc
Form 483 issued June 28, 2024 · Fort Mill, South Carolina
- Inspection
- Jun 26 – Jun 28, 2024
- Investigator
- Gamal A. Norton
- Observations
- 5
- Pages
- 4
- FEI number
- 1000126034
In short: On June 28, 2024, FDA issued a Form 483 with 5 observations to Simpex Medical Inc in Fort Mill, South Carolina (FEI 1000126034) after an inspection that ran Jun 26 – Jun 28, 2024. The investigator was Gamal A. Norton. Most observations concern production & process controls and design controls.
At a glance
4 of 5 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Design plans that describe or reference the design and development activities and define responsibility for implementation…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
Sampling plans are not written and based…
- 04
The DHR does not include records of examination and release of device labeling, including date and…
This inspection in context
Gamal A. Norton
16 documents · 2003–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in North Carolina.
The firmSimpex Medical Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Simpex Medical Inc?
FDA listed 5 observations on this Form 483, mostly about production & process controls and design controls. The opening words of each observation are shown on this page.
Who inspected Simpex Medical Inc?
Gamal A. Norton is named on this Form 483, for the inspection of Jun 26 – Jun 28, 2024. Each investigator has a profile showing what they cite most.
When was Simpex Medical Inc inspected by FDA?
The inspection ran Jun 26 – Jun 28, 2024, and the Form 483 is dated June 28, 2024.
How do I get the full Form 483 for Simpex Medical Inc?
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.