Massco Dental
Form 483 issued August 18, 2016 · Rogers, Arkansas
- Inspection
- Aug 16 – Aug 18, 2016
- Investigator
- Shatina R. Alridge
- Observations
- 2
- Pages
- 2
- FEI number
- 3001238690
In short: On August 18, 2016, FDA issued a Form 483 with 2 observations to Massco Dental in Rogers, Arkansas (FEI 3001238690) after an inspection that ran Aug 16 – Aug 18, 2016. The investigator was Shatina R. Alridge. Most observations concern production; the most-cited regulation is 21 CFR 211.105 (equipment identification).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.105(a) (1×) · 211.110(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
All used during the production of a batch of drug product is not properly identified at…
- 02
Control procedures are not established which of those manufacturing processes that may be responsible for causing…
This inspection in context
Shatina R. Alridge
10 documents · 2015–2020
Cites 110.35 (sanitary operations) more than any other section. Most of their documents are for sites in Texas.
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 211.105(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Massco Dental?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.105 (equipment identification). The opening words of each observation are shown on this page.
Who inspected Massco Dental?
Shatina R. Alridge is named on this Form 483, for the inspection of Aug 16 – Aug 18, 2016. Each investigator has a profile showing what they cite most.
When was Massco Dental inspected by FDA?
The inspection ran Aug 16 – Aug 18, 2016, and the Form 483 is dated August 18, 2016.
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.