Ambient Healthcare of Central Florida Inc.
Form 483 issued May 23, 2014 · Ocala, Florida
- Inspection
- May 12 – May 23, 2014
- Investigators
- Joanne E. King· Lacresha D. Chatman· Lesley K. Satterwhite
- Observations
- 6
- Pages
- 4
- FEI number
- 3010810839
In short: On May 23, 2014, FDA issued a Form 483 with 6 observations to Ambient Healthcare of Central Florida Inc. in Ocala, Florida (FEI 3010810839) after an inspection that ran May 12 – May 23, 2014. The investigators were Joanne E. King, Lacresha D. Chatman and Lesley K. Satterwhite. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
4 of 6 observations on this 483 concern facilities & equipment.
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
Aseptic processing areas are deficient in that walls are not smooth and/or bard surfaces…
- 02
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Joanne E. King
34 documents · 2013–2026
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 6 observations on this Form 483, mostly about facilities & equipment and production. 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.?
Joanne E. King, Lacresha D. Chatman and Lesley K. Satterwhite are named on this Form 483, for the inspection of May 12 – May 23, 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 May 12 – May 23, 2014, and the Form 483 is dated May 23, 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.