Poulsbo Compounding Pharmacy LLC, dba Cascade Specialty Pharmacy
Form 483 issued April 17, 2019 · Poulsbo, Washington
- Inspection
- Mar 11 – Apr 17, 2019
- Investigator
- Roger F. Zabinski
- Observations
- 7
- Pages
- 8
- FEI number
- 3015133983
In short: On April 17, 2019, FDA issued a Form 483 with 7 observations to Poulsbo Compounding Pharmacy LLC, dba Cascade Specialty Pharmacy in Poulsbo, Washington (FEI 3015133983) after an inspection that ran Mar 11 – Apr 17, 2019. The investigator was Roger F. Zabinski. 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 6 of 7 observations.
Most cited: 21 CFR 211.113 (3×) · 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was…
- 02
Inadequately protected product intended to be sterile was exposed to lower than ISO 5 classified aseptic…
- 03
You produced beta-lactam mugs without providing adequate containment, segregation, cleaning of work surfaces, cleaning of utensils…
- 04
Yom facility design allowed the influx of poor quality air into…
This inspection in context
Roger F. Zabinski
36 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmPoulsbo Compounding Pharmacy LLC, dba Cascade Specialty 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 Poulsbo Compounding Pharmacy LLC, dba Cascade Specialty Pharmacy?
FDA listed 7 observations on this Form 483, mostly about production, facilities & equipment and materials. 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 Poulsbo Compounding Pharmacy LLC, dba Cascade Specialty Pharmacy?
Roger F. Zabinski is named on this Form 483, for the inspection of Mar 11 – Apr 17, 2019. Each investigator has a profile showing what they cite most.
When was Poulsbo Compounding Pharmacy LLC, dba Cascade Specialty Pharmacy inspected by FDA?
The inspection ran Mar 11 – Apr 17, 2019, and the Form 483 is dated April 17, 2019.
How do I get the full Form 483 for Poulsbo Compounding Pharmacy LLC, dba Cascade Specialty 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.