Massco Dental
Form 483 issued September 2, 2022 · Rogers, Arkansas
- Inspection
- Aug 29 – Sep 2, 2022
- Investigator
- Kayla V. Sprague
- Observations
- 7
- Pages
- 7
- FEI number
- 3001238690
In short: On September 2, 2022, FDA issued a Form 483 with 7 observations to Massco Dental in Rogers, Arkansas (FEI 3001238690) after an inspection that ran Aug 29 – Sep 2, 2022. The investigator was Kayla V. Sprague. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
- 03
There is no quality…
- 04
Specific identification tests are not conducted on components that have been accepted based on the…
This inspection in context
Kayla V. Sprague
17 documents · 2020–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Florida.
The firmMassco Dental history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Massco Dental?
FDA listed 7 observations on this Form 483, mostly about production, quality system and materials. The opening words of each observation are shown on this page.
Who inspected Massco Dental?
Kayla V. Sprague is named on this Form 483, for the inspection of Aug 29 – Sep 2, 2022. Each investigator has a profile showing what they cite most.
When was Massco Dental inspected by FDA?
The inspection ran Aug 29 – Sep 2, 2022, and the Form 483 is dated September 2, 2022.
How do I get the full Form 483 for Massco Dental?
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.