Ambient Healthcare of Central Florida Inc.
Form 483 issued October 4, 2024 · Ocala, Florida
- Inspection
- Oct 1 – Oct 4, 2024
- Investigator
- Jessica P. McAlister
- Observations
- 2
- Pages
- 4
- FEI number
- 3010810839
In short: On October 4, 2024, FDA issued a Form 483 with 2 observations to Ambient Healthcare of Central Florida Inc. in Ocala, Florida (FEI 3010810839) after an inspection that ran Oct 1 – Oct 4, 2024. The investigator was Jessica P. McAlister.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(b)
Your firm released drug product in which the strength differs from, or its purity or quality…
- 02FDCA 501(a)(2)(A)
Contamination was observed in your production ai·ea and areas…
This inspection in context
Jessica P. McAlister
7 documents · 2021–2024
Cites FDCA 501(a)(2)(A) (insanitary conditions) 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.
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Questions about this 483
What did FDA find at Ambient Healthcare of Central Florida Inc.?
FDA listed 2 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Ambient Healthcare of Central Florida Inc.?
Jessica P. McAlister is named on this Form 483, for the inspection of Oct 1 – Oct 4, 2024. Each investigator has a profile showing what they cite most.
When was Ambient Healthcare of Central Florida Inc. inspected by FDA?
The inspection ran Oct 1 – Oct 4, 2024, and the Form 483 is dated October 4, 2024.
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.