Ambient Healthcare of Central Florida Inc.
Form 483 issued September 15, 2014 · Ocala, Florida
- Inspection
- Aug 26 – Sep 15, 2014
- Investigator
- Michael H. Tollon
- Observations
- 7
- Pages
- 3
- FEI number
- 3010810839
In short: On September 15, 2014, FDA issued a Form 483 with 7 observations to Ambient Healthcare of Central Florida Inc. in Ocala, Florida (FEI 3010810839) after an inspection that ran Aug 26 – Sep 15, 2014. The investigator was Michael H. Tollon. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 5 of 7 observations.
Most cited: 21 CFR 211.42 (3×)
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…
- 02
Protective apparel is not worn as necessary to protect…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
This inspection in context
Michael H. Tollon
12 documents · 2013–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmAmbient Healthcare of Central Florida Inc. history
All 3 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 Ambient Healthcare of Central Florida Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 Ambient Healthcare of Central Florida Inc.?
Michael H. Tollon is named on this Form 483, for the inspection of Aug 26 – Sep 15, 2014. Each investigator has a profile showing what they cite most.
When was Ambient Healthcare of Central Florida Inc. inspected by FDA?
The inspection ran Aug 26 – Sep 15, 2014, and the Form 483 is dated September 15, 2014.
How do I get the full Form 483 for Ambient Healthcare of Central Florida Inc.?
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.