Vital Rx, Inc. dba Atlantic Pharmacy and Compounding
Form 483 issued July 20, 2017 · Pompano Beach, Florida
- Inspection
- Jun 26 – Jul 20, 2017
- Investigator
- Joanne E. King
- Observations
- 6
- Pages
- 6
- FEI number
- 3011775721
In short: On July 20, 2017, FDA issued a Form 483 with 6 observations to Vital Rx, Inc. dba Atlantic Pharmacy and Compounding in Pompano Beach, Florida (FEI 3011775721) after an inspection that ran Jun 26 – Jul 20, 2017. The investigator was Joanne E. King. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 5 of 6 observations.
Most cited: 21 CFR 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
We observed preparations and reviewed documentation for sterile diug products such as multi-use vials for intravenous…
- 03
Your firm failed to perform adequate media fill studies in that they did not closely simulate…
- 04
Your firm does not perform environmental monitoring for microorganisms. Your are not monitoring your sterile ISO…
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 firmVital Rx, Inc. dba Atlantic Pharmacy and Compounding history
All 2 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 Vital Rx, Inc. dba Atlantic Pharmacy and Compounding?
FDA listed 6 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 Vital Rx, Inc. dba Atlantic Pharmacy and Compounding?
Joanne E. King is named on this Form 483, for the inspection of Jun 26 – Jul 20, 2017. Each investigator has a profile showing what they cite most.
When was Vital Rx, Inc. dba Atlantic Pharmacy and Compounding inspected by FDA?
The inspection ran Jun 26 – Jul 20, 2017, and the Form 483 is dated July 20, 2017.
How do I get the full Form 483 for Vital Rx, Inc. dba Atlantic Pharmacy and Compounding?
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.