University Pharmacy, Inc.
Form 483 issued February 26, 2013 · Salt Lake City, Utah
- Inspection
- Feb 19 – Feb 26, 2013
- Investigators
- Erika V. Butler· Zachery L. Miller
- Observations
- 6
- Pages
- 5
- FEI number
- 3004146124
In short: On February 26, 2013, FDA issued a Form 483 with 6 observations to University Pharmacy, Inc. in Salt Lake City, Utah (FEI 3004146124) after an inspection that ran Feb 19 – Feb 26, 2013. The investigators were Erika V. Butler and Zachery L. Miller. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and laboratory controls account for 4 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
Equipment and utensils are not sanitized at appropriate intervals to prevent contamination that would alter the…
- 02
Testing and release ofdrug product for d istrjbution do not include appropriate laboratory detennination of satisfactory…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Erika V. Butler
23 documents · 2007–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmUniversity Pharmacy, Inc. history
The site's inspection history, in date order.
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 University Pharmacy, Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. 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 University Pharmacy, Inc.?
Erika V. Butler and Zachery L. Miller are named on this Form 483, for the inspection of Feb 19 – Feb 26, 2013. Each investigator has a profile showing what they cite most.
When was University Pharmacy, Inc. inspected by FDA?
The inspection ran Feb 19 – Feb 26, 2013, and the Form 483 is dated February 26, 2013.
How do I get the full Form 483 for University 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.