AnazaoHealth Corporation
Form 483 issued January 30, 2015 · Las Vegas, Nevada
- Inspection
- Jan 30, 2015
- Investigators
- Eileen A. Liu· Lucila B. Nwatu
- Observations
- 10
- Pages
- 10
- FEI number
- 3011152407
In short: On January 30, 2015, FDA issued a Form 483 with 10 observations to AnazaoHealth Corporation in Las Vegas, Nevada (FEI 3011152407) after an inspection that ran Jan 30, 2015. The investigators were Eileen A. Liu and Lucila B. Nwatu. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (3×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Laboratory controls do not include the establishment ofscientifically sound and appropriate specifications, sampling plans, and test…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Eileen A. Liu
41 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AnazaoHealth Corporation?
FDA listed 10 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected AnazaoHealth Corporation?
Eileen A. Liu and Lucila B. Nwatu are named on this Form 483, for the inspection of Jan 30, 2015. Each investigator has a profile showing what they cite most.
When was AnazaoHealth Corporation inspected by FDA?
The inspection ran Jan 30, 2015, and the Form 483 is dated January 30, 2015.
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.