Jubilant Draximage Radiopharmacies Inc.
Form 483 issued March 5, 2024 · Orlando, Florida
- Inspection
- Mar 5, 2024
- Investigators
- Jared P. Stevens· Jessica P. McAlister
- Observations
- 6
- Pages
- 4
- FEI number
- 3009339218
In short: On March 5, 2024, FDA issued a Form 483 with 6 observations to Jubilant Draximage Radiopharmacies Inc. in Orlando, Florida (FEI 3009339218) after an inspection that ran Mar 5, 2024. The investigators were Jared P. Stevens and Jessica P. McAlister.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Personnel were observed perfonning aseptic processing outside of…
- 02FDCA 501(a)(2)(A)
Personnel were observed conducting aseptic manipulations where the movement of 11 first air" in the ISO…
- 03FDCA 501(a)(2)(A)
EM Pl.OYEE(S) SIGNATURE Use of non-sterile disinfecting agents and cleaning pads in…
- 04FDCA 501(a)(2)(A)
Smoke studies were inadequately…
This inspection in context
Jared P. Stevens
15 documents · 2017–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in South Carolina.
The firmJubilant Draximage Radiopharmacies Inc. history
All 2 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 Jubilant Draximage Radiopharmacies Inc.?
FDA listed 6 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Jubilant Draximage Radiopharmacies Inc.?
Jared P. Stevens and Jessica P. McAlister are named on this Form 483, for the inspection of Mar 5, 2024. Each investigator has a profile showing what they cite most.
When was Jubilant Draximage Radiopharmacies Inc. inspected by FDA?
The inspection ran Mar 5, 2024, and the Form 483 is dated March 5, 2024.
How do I get the full Form 483 for Jubilant Draximage Radiopharmacies 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.