Joe Wise Pharmacy, Inc.
Form 483 issued June 21, 2019 · Littleton, Colorado
- Inspection
- Jun 12 – Jun 21, 2019
- Investigator
- Jamie L. Dion
- Observations
- 6
- Pages
- 3
- FEI number
- 3004995630
In short: On June 21, 2019, FDA issued a Form 483 with 6 observations to Joe Wise Pharmacy, Inc. in Littleton, Colorado (FEI 3004995630) after an inspection that ran Jun 12 – Jun 21, 2019. The investigator was Jamie L. Dion. 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 6 observations.
Most cited: 21 CFR 211.42 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The classified TSO 5 aseptic processing area was located within a non-classifed…
- 02
Observation 2: scanned text, readable in the full document.
- 03
You produced hazardous drugs without providing adequate containment and cleaning of work…
- 04
You used a non-pharmaceutical grade component in the formulation…
This inspection in context
Jamie L. Dion
11 documents · 2013–2019
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Colorado.
The firmJoe Wise Pharmacy, 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 Joe Wise Pharmacy, 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 Joe Wise Pharmacy, Inc.?
Jamie L. Dion is named on this Form 483, for the inspection of Jun 12 – Jun 21, 2019. Each investigator has a profile showing what they cite most.
When was Joe Wise Pharmacy, Inc. inspected by FDA?
The inspection ran Jun 12 – Jun 21, 2019, and the Form 483 is dated June 21, 2019.
How do I get the full Form 483 for Joe Wise Pharmacy, 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.