Pharmacy Resources Incorporated
Form 483 issued May 23, 2017 · Denver, Colorado
- Inspection
- May 8 – May 23, 2017
- Investigator
- Zachery L. Miller
- Observations
- 7
- Pages
- 6
- FEI number
- 3002946837
In short: On May 23, 2017, FDA issued a Form 483 with 7 observations to Pharmacy Resources Incorporated in Denver, Colorado (FEI 3002946837) after an inspection that ran May 8 – May 23, 2017. The investigator was Zachery L. Miller. 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 7 observations.
Most cited: 21 CFR 211.42 (2×)
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 regarding the system for cleaning an d disinfecting the room and…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Zachery L. Miller
17 documents · 2011–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Colorado.
The firmPharmacy Resources Incorporated 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 Pharmacy Resources Incorporated?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 Pharmacy Resources Incorporated?
Zachery L. Miller is named on this Form 483, for the inspection of May 8 – May 23, 2017. Each investigator has a profile showing what they cite most.
When was Pharmacy Resources Incorporated inspected by FDA?
The inspection ran May 8 – May 23, 2017, and the Form 483 is dated May 23, 2017.
How do I get the full Form 483 for Pharmacy Resources Incorporated?
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.