Form FDA 483 · Issued 2026-01-15
Donor Alliance, Inc. — FDA Form 483 Analysis
FEI: 3000215347 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Human Tissue Establishment) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to Donor Alliance, Inc. (FEI 3000215347) on 2026-01-15 following an inspection of its human tissue establishment operations in Colorado. The report documents 3 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.89
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Quarantine of Rejected Components et. al.
Inspector Observation Language: "Rejected [components] [drug product containers] [closures] are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable. Specifically, observed during inspection of Donor Alliance, Inc. on 2026-01-15."
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 #2 · 21 CFR 211.110(d)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Rejected in-process materials not quarantined
Inspector Observation Language: "Rejected in-process materials are not [identified] [controlled under a quarantine system] to prevent their use in manufacturing or processing operations for which they are unsuitable. Specifically, observed during inspection of Donor Alliance, Inc. on 2026-01-15."
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 · 21 CFR 211.56(b)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Written sanitation procedures not followed
Inspector Observation Language: "Written procedures for sanitation are not followed. Specifically, observed during inspection of Donor Alliance, Inc. on 2026-01-15."
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.