Poulsbo Compounding Pharmacy LLC, dba Cascade Specialty Pharmacy
Form 483 issued July 17, 2026 · Poulsbo, Washington
- Inspection
- Jul 6 – Jul 17, 2026
- Investigators
- Lillian S. Wu· Youkeun Kim
- Observations
- 6
- Pages
- 6
- FEI number
- 3015133983
In short: On July 17, 2026, FDA issued a Form 483 with 6 observations to Poulsbo Compounding Pharmacy LLC, dba Cascade Specialty Pharmacy in Poulsbo, Washington (FEI 3015133983) after an inspection that ran Jul 6 – Jul 17, 2026. The investigators were Lillian S. Wu and Youkeun Kim. Most observations concern laboratory controls and quality system.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Lillian S. Wu
11 documents · 2022–2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) 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 211.22
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 6 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected Poulsbo Compounding Pharmacy LLC, dba Cascade Specialty Pharmacy?
Lillian S. Wu and Youkeun Kim are named on this Form 483, for the inspection of Jul 6 – Jul 17, 2026. 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 Jul 6 – Jul 17, 2026, and the Form 483 is dated July 17, 2026.
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.