Kelley-Ross Compounding Pharmacy
Form 483 issued September 23, 2020 · Sea ttle, Washington
- Inspection
- Sep 8 – Sep 23, 2020
- Investigator
- Christopher R. Czajka
- Observations
- 5
- Pages
- 4
- FEI number
- 3013436443
In short: On September 23, 2020, FDA issued a Form 483 with 5 observations to Kelley-Ross Compounding Pharmacy in Sea ttle, Washington (FEI 3013436443) after an inspection that ran Sep 8 – Sep 23, 2020. The investigator was Christopher R. Czajka.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Materials or supplies were not disinfected prior to entering…
- 02FDCA 501(a)(2)(A)
Your facility design allowed the influx of poor quality air into…
- 03FDCA 501(a)(2)(A)
The ISO 5 classifi ed aseptic processing areas had difficult to clean and visibly…
- 04FDCA 501(a)(2)(A)
Personnel donned gowning apparel improperly, in a way that may have caused the gowning…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmKelley-Ross Compounding Pharmacy history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Kelley-Ross Compounding Pharmacy?
FDA listed 5 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Kelley-Ross Compounding Pharmacy?
Christopher R. Czajka is named on this Form 483, for the inspection of Sep 8 – Sep 23, 2020. Each investigator has a profile showing what they cite most.
When was Kelley-Ross Compounding Pharmacy inspected by FDA?
The inspection ran Sep 8 – Sep 23, 2020, and the Form 483 is dated September 23, 2020.
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.