AnazaoHealth Corporation
Form 483 issued May 7, 2018 · Tampa, Florida
- Inspection
- Apr 9 – May 7, 2018
- Investigators
- Christie A. Soto· Jennifer L. Huntington· Joanne E. King
- Observations
- 13
- Pages
- 12
- FEI number
- 3004483463
In short: On May 7, 2018, FDA issued a Form 483 with 13 observations to AnazaoHealth Corporation in Tampa, Florida (FEI 3004483463) after an inspection that ran Apr 9 – May 7, 2018. The investigators were Christie A. Soto, Jennifer L. Huntington and Joanne E. King. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: FDCA 501(a)(2)(A) (6×)
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
You used a non-pharmaceutical grade component in the formulation…
- 02
Procedures designed to prevent Inicrobiological contamination of diug products purporting to be sterile are not…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Christie A. Soto
1 document · 2018
Cites FDCA 501(a)(2)(A) (insanitary conditions) 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AnazaoHealth Corporation?
FDA listed 13 observations on this Form 483, mostly about facilities & equipment, production and materials. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected AnazaoHealth Corporation?
Christie A. Soto, Jennifer L. Huntington and Joanne E. King are named on this Form 483, for the inspection of Apr 9 – May 7, 2018. Each investigator has a profile showing what they cite most.
When was AnazaoHealth Corporation inspected by FDA?
The inspection ran Apr 9 – May 7, 2018, and the Form 483 is dated May 7, 2018.
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.