Form FDA 483 · Issued 2025-12-11
Denver Solutions, LLC — FDA Form 483 Analysis
FEI: 3013438582 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Outsourcing Facility) · Lead Investigator: David K. Chen
FDA Form 483 issued to Denver Solutions, LLC (FEI 3013438582) on 2025-12-11 following an inspection of its outsourcing facility operations in Colorado. The report documents 4 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · FDCA 505-1(f)(3)(B)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Failure to comply with REMS Elements to Assure Safe Use (ETASU) B
Inspector Observation Language: "An application holder did not [ensure pharmacies that dispense the drug are specially certified] [ensure mechanisms are in place that allow pharmacies the ability to complete the certification process] [maintain a validated, secure database of certified pharmacies] [identify and address non-compliant certified pharmacies], as required by your approved REMS Element to Assure Safe Use (ETASU) B. Specifically, observed during inspection of Denver Solutions, LLC on 2025-12-11."
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 · FDCA 501(a)(2)(A)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Sporicidal agent, ISO 5/classified areas
Inspector Observation Language: "Use of a sporicidal agent in the facility's [ISO 5 areas] [classified areas] was [lacking] [improper] [infrequent]. Specifically, observed during inspection of Denver Solutions, LLC on 2025-12-11."
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 #3 · FDCA 503B(a)(10)(B)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Drug product container, fails to include
Inspector Observation Language: "The container of your outsourcing facility's drug products does not include information required by section 503B(a)(10)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, observed during inspection of Denver Solutions, LLC on 2025-12-11."
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 #4 · 21 CFR 211.67(b)(6)
Cleaning Validation, Sanitation Logs & Pest Control
REPEAT CITATION AT FACILITY
Cleaning SOP/inspection
Inspector Observation Language: "Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use. Specifically, observed during inspection of Denver Solutions, LLC on 2025-12-11."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.