University of Washington Medical Center Inpatient Pharmacy
Form 483 issued August 4, 2016 · Seattle, Washington
- Inspection
- Jul 11 – Aug 4, 2016
- Investigators
- De Leon· Gloria J. Baca
- Observations
- 8
- Pages
- 5
- FEI number
- 3012562031
In short: On August 4, 2016, FDA issued a Form 483 with 8 observations to University of Washington Medical Center Inpatient Pharmacy in Seattle, Washington (FEI 3012562031) after an inspection that ran Jul 11 – Aug 4, 2016. The investigators were De Leon and Gloria J. Baca. 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 6 of 8 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
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 02
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 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 sterile are…
This inspection in context
De Leon
2 documents · 2016
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Washington.
The firmUniversity of Washington Medical Center Inpatient Pharmacy history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at University of Washington Medical Center Inpatient Pharmacy?
FDA listed 8 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 University of Washington Medical Center Inpatient Pharmacy?
De Leon and Gloria J. Baca are named on this Form 483, for the inspection of Jul 11 – Aug 4, 2016. Each investigator has a profile showing what they cite most.
When was University of Washington Medical Center Inpatient Pharmacy inspected by FDA?
The inspection ran Jul 11 – Aug 4, 2016, and the Form 483 is dated August 4, 2016.
How do I get the full Form 483 for University of Washington Medical Center Inpatient Pharmacy?
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.