AnazaoHealth Corporation
Form 483 issued August 8, 2025 · Las Vegas, Nevada
- Inspection
- Jul 28 – Aug 8, 2025
- Investigator
- Taichun Qin
- Observations
- 4
- Pages
- 5
- FEI number
- 3011152407
In short: On August 8, 2025, FDA issued a Form 483 with 4 observations to AnazaoHealth Corporation in Las Vegas, Nevada (FEI 3011152407) after an inspection that ran Jul 28 – Aug 8, 2025. The investigator was Taichun Qin. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your fum failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Complaint records are deficient in that they do not include the findings of the…
- 04
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) 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 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AnazaoHealth Corporation?
FDA listed 4 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected AnazaoHealth Corporation?
Taichun Qin is named on this Form 483, for the inspection of Jul 28 – Aug 8, 2025. Each investigator has a profile showing what they cite most.
When was AnazaoHealth Corporation inspected by FDA?
The inspection ran Jul 28 – Aug 8, 2025, and the Form 483 is dated August 8, 2025.
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.