AnazaoHealth Corporation
Form 483 issued September 19, 2019 · Las Vegas, Nevada
- Inspection
- Sep 9 – Sep 19, 2019
- Investigator
- Zachery L. Miller
- Observations
- 3
- Pages
- 3
- FEI number
- 3011152407
In short: On September 19, 2019, FDA issued a Form 483 with 3 observations to AnazaoHealth Corporation in Las Vegas, Nevada (FEI 3011152407) after an inspection that ran Sep 9 – Sep 19, 2019. The investigator was Zachery L. Miller. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42(c)(10)(v) (1×) · 211.42(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 02
The flow of components, drug product containers, closures and in-process materials through the building is not…
- 03
Bulk drug substances used by your outsourcing facility to compound drug products are not each manufactured…
This inspection in context
Zachery L. Miller
17 documents · 2011–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Colorado.
The firmAnazaoHealth Corporation history
All 10 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(v)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AnazaoHealth Corporation?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected AnazaoHealth Corporation?
Zachery L. Miller is named on this Form 483, for the inspection of Sep 9 – Sep 19, 2019. Each investigator has a profile showing what they cite most.
When was AnazaoHealth Corporation inspected by FDA?
The inspection ran Sep 9 – Sep 19, 2019, and the Form 483 is dated September 19, 2019.
How do I get the full Form 483 for AnazaoHealth Corporation?
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.