Kelley-Ross Compounding Pharmacy
Form 483 issued August 2, 2017 · Seattle, Washington
- Inspection
- Aug 1, 2017
- Investigators
- Gerard P. De Leon· Kenneth O. Gee
- Observations
- 7
- Pages
- 4
- FEI number
- 3013436443
In short: On August 2, 2017, FDA issued a Form 483 with 7 observations to Kelley-Ross Compounding Pharmacy in Seattle, Washington (FEI 3013436443) after an inspection that ran Aug 1, 2017. The investigators were Gerard P. De Leon and Kenneth O. Gee. 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 7 of 7 observations.
Most cited: 21 CFR 211.113 (5×) · 211.67 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment, materials, and/or supplies are not disinfected prior to entering…
- 02
The ISO-classified areas have difficult to clean, particle-generating…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Environmental monitoring was not performed in…
This inspection in context
Gerard P. De Leon
9 documents · 2015–2017
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Washington.
The firmKelley-Ross Compounding Pharmacy history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kelley-Ross Compounding Pharmacy?
FDA listed 7 observations on this Form 483, mostly about production and facilities & equipment. 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 Kelley-Ross Compounding Pharmacy?
Gerard P. De Leon and Kenneth O. Gee are named on this Form 483, for the inspection of Aug 1, 2017. Each investigator has a profile showing what they cite most.
When was Kelley-Ross Compounding Pharmacy inspected by FDA?
The inspection ran Aug 1, 2017, and the Form 483 is dated August 2, 2017.
How do I get the full Form 483 for Kelley-Ross Compounding 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.