AnazaoHealth Corporation
Amended 483 issued March 24, 2017 · Las Vegas, Nevada
- Inspection
- Mar 15 – Mar 24, 2017
- Investigators
- Ashar P. Parikh· Eileen A. Liu· Rumany C. Penn
- Observations
- 9
- Pages
- 6
- FEI number
- 3011152407
In short: On March 24, 2017, FDA issued a Amended 483 with 9 observations to AnazaoHealth Corporation in Las Vegas, Nevada (FEI 3011152407) after an inspection that ran Mar 15 – Mar 24, 2017. The investigators were Ashar P. Parikh, Eileen A. Liu and Rumany C. Penn. 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 (2×) · 211.165 (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
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
Drug products failing to meet established specifications and quality control…
- 04
Employees engaged in the processing of a drug product lack the training required to…
5 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Ashar P. Parikh
19 documents · 2014–2026
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 documentsOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at AnazaoHealth Corporation?
FDA listed 9 observations on this Form 483, mostly about production, laboratory controls and quality system. 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?
Ashar P. Parikh, Eileen A. Liu and Rumany C. Penn are named on this Amended 483, for the inspection of Mar 15 – Mar 24, 2017. Each investigator has a profile showing what they cite most.
When was AnazaoHealth Corporation inspected by FDA?
The inspection ran Mar 15 – Mar 24, 2017, and the Amended 483 is dated March 24, 2017.
How do I get the full Amended 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.