AnazaoHealth Corporation
Form 483 issued December 23, 2009 · Tampa, Florida
- Inspection
- Dec 1 – Dec 23, 2009
- Investigators
- Mihaly S. Ligmond· Page Zielny
- Observations
- 18
- Pages
- 9
- FEI number
- 3004483463
In short: On December 23, 2009, FDA issued a Form 483 with 18 observations to AnazaoHealth Corporation in Tampa, Florida (FEI 3004483463) after an inspection that ran Dec 1 – Dec 23, 2009. The investigators were Mihaly S. Ligmond and Page Zielny. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.42 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no designated Quality Control Unit…
- 02
There is a lack of separate or defmed areas or other control systems for the ftrm's…
- 03
Personnel engaged in the making ofradiopharmaceuticals in the Nuclear Pharmacy failed to wear appropriate protective apparel…
- 04
Gowning practices in the Nuclear Pharmacy are inappropriate for the aseptic processing ofradiopharmaceuticals…
This inspection in context
Mihaly S. Ligmond
20 documents · 2006–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ireland.
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AnazaoHealth Corporation?
FDA listed 18 observations on this Form 483, mostly about production, laboratory controls and quality system. 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?
Mihaly S. Ligmond and Page Zielny are named on this Form 483, for the inspection of Dec 1 – Dec 23, 2009. Each investigator has a profile showing what they cite most.
When was AnazaoHealth Corporation inspected by FDA?
The inspection ran Dec 1 – Dec 23, 2009, and the Form 483 is dated December 23, 2009.
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.