GPS DENTAL LAB, INC
Form 483 issued November 5, 2024 · Orlando, Florida
- Inspection
- Oct 31 – Nov 5, 2024
- Investigator
- Brandon P. Thompson
- Observations
- 12
- Pages
- 20
- FEI number
- 3020064003
In short: On November 5, 2024, FDA issued a Form 483 with 12 observations to GPS DENTAL LAB, INC in Orlando, Florida (FEI 3020064003) after an inspection that ran Oct 31 – Nov 5, 2024. The investigator was Brandon P. Thompson. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
Production & process controls and capa account for 8 of 12 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 02
Procedures have not been established to control product that does not…
- 03
Procedures for corrective and preventive action have…
- 04
Procedures to ensure equipment is routinely calibrated, inspected, checked and maintained have…
This inspection in context
Brandon P. Thompson
3 documents · 2022–2025
Cites 820.20(b) (management responsibility) more than any other section. Most of their documents are for sites in Florida.
The firmGPS DENTAL LAB, INC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at GPS DENTAL LAB, INC?
FDA listed 12 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
Who inspected GPS DENTAL LAB, INC?
Brandon P. Thompson is named on this Form 483, for the inspection of Oct 31 – Nov 5, 2024. Each investigator has a profile showing what they cite most.
When was GPS DENTAL LAB, INC inspected by FDA?
The inspection ran Oct 31 – Nov 5, 2024, and the Form 483 is dated November 5, 2024.
How do I get the full Form 483 for GPS DENTAL LAB, 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.