Sun Dental Laboratories, LLC
Form 483 issued September 20, 2023 · Saint Petersburg, Florida
- Inspection
- Sep 19 – Sep 20, 2023
- Investigator
- Suzanne M. Healy
- Observations
- 3
- Pages
- 4
- FEI number
- 3006430881
In short: On September 20, 2023, FDA issued a Form 483 with 3 observations to Sun Dental Laboratories, LLC in Saint Petersburg, Florida (FEI 3006430881) after an inspection that ran Sep 19 – Sep 20, 2023. The investigator was Suzanne M. Healy. Most observations concern production & process controls and cAPA.
At a glance
2 of 3 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have…
- 02
There is no agreement with suppliers and contractors to notify you of changes in…
- 03
Labeling was not sufficiently examined by a designated individual for accuracy including unique device identifier (UDI)…
This inspection in context
Suzanne M. Healy
5 documents · 2017–2023
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmSun Dental Laboratories, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sun Dental Laboratories, LLC?
FDA listed 3 observations on this Form 483, mostly about production & process controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Sun Dental Laboratories, LLC?
Suzanne M. Healy is named on this Form 483, for the inspection of Sep 19 – Sep 20, 2023. Each investigator has a profile showing what they cite most.
When was Sun Dental Laboratories, LLC inspected by FDA?
The inspection ran Sep 19 – Sep 20, 2023, and the Form 483 is dated September 20, 2023.
How do I get the full Form 483 for Sun Dental Laboratories, LLC?
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.