Diamond Orthopedic
Form 483 issued April 5, 2019 · Charlotte, North Carolina
- Inspection
- Mar 25 – Apr 5, 2019
- Investigator
- Gamal A. Norton
- Observations
- 11
- Pages
- 8
- FEI number
- 3013540005
In short: On April 5, 2019, FDA issued a Form 483 with 11 observations to Diamond Orthopedic in Charlotte, North Carolina (FEI 3013540005) after an inspection that ran Mar 25 – Apr 5, 2019. The investigator was Gamal A. Norton. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
CAPA and production & process controls account for 8 of 11 observations.
Most cited: 21 CFR 820.22 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Complaints representing events that are MDR reportable were not promptly reviewed, evaluated, and investigated by a…
- 02
The DHR does not include records of examination and release of device labeling, including date and…
- 03
Procedures that define the responsibility for review and the authority for the disposition of nonconforming product…
- 04
Procedures have not been adequately established to control product that does not…
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 firmDiamond Orthopedic history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Diamond Orthopedic?
FDA listed 11 observations on this Form 483, mostly about cAPA, production & process controls and management controls. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected Diamond Orthopedic?
Gamal A. Norton is named on this Form 483, for the inspection of Mar 25 – Apr 5, 2019. Each investigator has a profile showing what they cite most.
When was Diamond Orthopedic inspected by FDA?
The inspection ran Mar 25 – Apr 5, 2019, and the Form 483 is dated April 5, 2019.
How do I get the full Form 483 for Diamond Orthopedic?
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.