Medshift
Form 483 issued December 13, 2024 · Charlotte, North Carolina
- Inspection
- Dec 10 – Dec 13, 2024
- Investigator
- Gamal A. Norton
- Observations
- 10
- Pages
- 6
- FEI number
- 3013462594
In short: On December 13, 2024, FDA issued a Form 483 with 10 observations to Medshift in Charlotte, North Carolina (FEI 3013462594) after an inspection that ran Dec 10 – Dec 13, 2024. The investigator was Gamal A. Norton. Most observations concern production & process controls and records & documents; the most-cited regulation is 21 CFR 820.50 (purchasing controls).
At a glance
Production & process controls and records & documents account for 7 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
- 02
Process validation activities and results have not…
- 03
There is no agreement with suppliers, contractors and consultants to notify you of changes in the…
- 04
The evaluation of potential suppliers, contractors 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 firmMedshift history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medshift?
FDA listed 10 observations on this Form 483, mostly about production & process controls, records & documents and management controls. The most-cited regulation is 21 CFR 820.50 (purchasing controls). The opening words of each observation are shown on this page.
Who inspected Medshift?
Gamal A. Norton is named on this Form 483, for the inspection of Dec 10 – Dec 13, 2024. Each investigator has a profile showing what they cite most.
When was Medshift inspected by FDA?
The inspection ran Dec 10 – Dec 13, 2024, and the Form 483 is dated December 13, 2024.
How do I get the full Form 483 for Medshift?
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.