AnazaoHealth Corporation
Form 483 issued May 9, 2019 · Tampa, Florida
- Inspection
- Apr 25 – May 9, 2019
- Investigator
- Jennifer L. Huntington
- Observations
- 5
- Pages
- 6
- FEI number
- 3004483463
In short: On May 9, 2019, FDA issued a Form 483 with 5 observations to AnazaoHealth Corporation in Tampa, Florida (FEI 3004483463) after an inspection that ran Apr 25 – May 9, 2019. The investigator was Jennifer L. Huntington. Most observations concern materials and production.
At a glance
Observations span 3 systems, led by materials.
Most cited: FDCA 501(a)(2)(A) (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01FDCA 501(a)(2)(A)
Observation 1: scanned text, readable in the full document.
- 02
You used a non-pharmaceutical grade component in the formulation…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
The written stability program for diug products does not include reliable, meaningful…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmAnazaoHealth Corporation history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
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 materials, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected AnazaoHealth Corporation?
Jennifer L. Huntington is named on this Form 483, for the inspection of Apr 25 – May 9, 2019. Each investigator has a profile showing what they cite most.
When was AnazaoHealth Corporation inspected by FDA?
The inspection ran Apr 25 – May 9, 2019, and the Form 483 is dated May 9, 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.