AnazaoHealth Corporation
Form 483 issued September 14, 2022 · Las Vegas, Nevada
- Inspection
- Jul 6 – Jul 29, 2022
- Investigator
- John A. Gonzalez
- Observations
- 5
- Pages
- 5
- FEI number
- 3011152407
In short: On September 14, 2022, FDA issued a Form 483 with 5 observations to AnazaoHealth Corporation in Las Vegas, Nevada (FEI 3011152407) after an inspection that ran Jul 6 – Jul 29, 2022. The investigator was John A. Gonzalez. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 3 of 5 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The qua lity unit lacks authori ty to review production records to assure that no errors…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
There is a fa ilure to thorough ly review the fai lure of a batch or…
- 04
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
This inspection in context
John A. Gonzalez
3 documents · 2021–2022
Cites 211.180 (general requirements) more than any other section. Most of their documents are for sites in California.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AnazaoHealth Corporation?
FDA listed 5 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected AnazaoHealth Corporation?
John A. Gonzalez is named on this Form 483, for the inspection of Jul 6 – Jul 29, 2022. Each investigator has a profile showing what they cite most.
When was AnazaoHealth Corporation inspected by FDA?
The inspection ran Jul 6 – Jul 29, 2022, and the Form 483 is dated September 14, 2022.
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.