Trackx Technology Inc
Form 483 issued August 14, 2024 · Hillsborough, North Carolina
- Inspection
- Aug 6 – Aug 14, 2024
- Investigators
- Christopher B. May· Shawn Choi
- Observations
- 2
- Pages
- 3
- FEI number
- 3014391847
In short: On August 14, 2024, FDA issued a Form 483 with 2 observations to Trackx Technology Inc in Hillsborough, North Carolina (FEI 3014391847) after an inspection that ran Aug 6 – Aug 14, 2024. The investigators were Christopher B. May and Shawn Choi. Most observations concern management controls and cAPA; the most-cited regulation is 21 CFR 820.22 (quality audit).
At a glance
Management controls and capa account for 2 of 2 observations.
Most cited: 21 CFR 820.22 (1×) · 820.90(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for quality audits have…
- 02
Products that do not conform to specifications…
This inspection in context
Christopher B. May
4 documents · 2022–2024
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in North Carolina.
The firmTrackx Technology Inc 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 Trackx Technology Inc?
FDA listed 2 observations on this Form 483, mostly about management controls and cAPA. The most-cited regulation is 21 CFR 820.22 (quality audit). The opening words of each observation are shown on this page.
Who inspected Trackx Technology Inc?
Christopher B. May and Shawn Choi are named on this Form 483, for the inspection of Aug 6 – Aug 14, 2024. Each investigator has a profile showing what they cite most.
When was Trackx Technology Inc inspected by FDA?
The inspection ran Aug 6 – Aug 14, 2024, and the Form 483 is dated August 14, 2024.
How do I get the full Form 483 for Trackx Technology 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.