AnazaoHealth Corporation
Form 483 issued February 22, 2013 · Tampa, Florida
- Inspection
- Feb 19 – Feb 22, 2013
- Investigators
- Ileana Barreto-Pettit· Lesley K. Satterwhite· Robert C. Steyert
- Observations
- 12
- Pages
- 7
- FEI number
- 3004483463
In short: On February 22, 2013, FDA issued a Form 483 with 12 observations to AnazaoHealth Corporation in Tampa, Florida (FEI 3004483463) after an inspection that ran Feb 19 – Feb 22, 2013. The investigators were Ileana Barreto-Pettit, Lesley K. Satterwhite and Robert C. Steyert. Most observations concern production and facilities & equipment; 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×) · 211.42 (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 are not…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Samples taken of drug products for determination of conformance to written…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Ileana Barreto-Pettit
25 documents · 2001–2022
Cites 211.42 (design and construction features) 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AnazaoHealth Corporation?
FDA listed 12 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. 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?
Ileana Barreto-Pettit, Lesley K. Satterwhite and Robert C. Steyert are named on this Form 483, for the inspection of Feb 19 – Feb 22, 2013. Each investigator has a profile showing what they cite most.
When was AnazaoHealth Corporation inspected by FDA?
The inspection ran Feb 19 – Feb 22, 2013, and the Form 483 is dated February 22, 2013.
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.