Form FDA 483 · Issued 2026-07-17
Cascade Specialty Pharmacy LLC — FDA Form 483 Analysis
FEI: 3015133983 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Producer of Non Sterile Drug Products) · Lead Investigator: Rebecca M. Okafor
FDA Form 483 issued to Cascade Specialty Pharmacy LLC (FEI 3015133983) on 2026-07-17 following an inspection of its producer of non sterile drug products operations in Washington. The report documents 4 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Personnel GMP Training, Gowning & Hygienic Practices.
Get Full Annotated 483 Dossier + CAPA Checklist
Instant PDF + CFR Matrix ($79 vs. Redica's $289)
Need Help Fixing These 4 Citations?
Get matched with a vetted 21 CFR remediation consultant
Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 211.42(c)(10)(iv)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Environmental Monitoring System
Inspector Observation Language: "Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, observed during inspection of Cascade Specialty Pharmacy LLC on 2026-07-17."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.
Observation #2 · 21 CFR 211.25(a)
Personnel GMP Training, Gowning & Hygienic Practices
REPEAT CITATION AT FACILITY
Training , Education , Experience overall
Inspector Observation Language: "Employees engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] required to perform their assigned functions. Specifically, observed during inspection of Cascade Specialty Pharmacy LLC on 2026-07-17."
Plain-English Meaning: Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
Standard CAPA Remediation Path: Maintain role-based SOP training matrices signed prior to independent floor assignment and annual cGMP refresher assessments.
Observation #3 · 21 CFR 211.84(d)(2)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Reports of Analysis (Components)
Inspector Observation Language: "Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without [performing at least one specific identity test on each component] [establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals]. Specifically, observed during inspection of Cascade Specialty Pharmacy LLC on 2026-07-17."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #4 · 21 CFR 211.58
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Buildings not maintained in good state of repair
Inspector Observation Language: "Buildings used in the [manufacturing] [processing] [packing] [holding] of a drug product are not maintained in a good state of repair. Specifically, observed during inspection of Cascade Specialty Pharmacy LLC on 2026-07-17."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.