Form FDA 483 · Issued 2025-12-18
Gold Star Distribution Inc. — FDA Form 483 Analysis
FEI: 3004388746 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Multi-commodity Ambient Warehouse) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Gold Star Distribution Inc. (FEI 3004388746) on 2025-12-18 following an inspection of its multi-commodity ambient warehouse operations in Minnesota. The report documents 2 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
Get Full Annotated 483 Dossier + CAPA Checklist
Instant PDF + CFR Matrix ($79 vs. Redica's $289)
Need Help Fixing These 2 Citations?
Get matched with a vetted 21 CFR remediation consultant
Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.165(d)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Acceptance/Rejection Levels
Inspector Observation Language: "The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels]. Specifically, observed during inspection of Gold Star Distribution Inc. on 2025-12-18."
Plain-English Meaning: Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
Standard CAPA Remediation Path: Require finished-batch microbiological (USP <2021>/<2022>), heavy metal, and active-assay release testing plus ICH stability chamber protocols supporting every label shelf-life claim.
Observation #2 · 21 CFR 314.81(b)(1)(ii)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Contamination, chemical or physical change, deterioration
Inspector Observation Language: "An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning [bacteriological contamination] [significant chemical, physical, or other change or deterioration] in a distributed drug product. Specifically, observed during inspection of Gold Star Distribution Inc. on 2025-12-18."
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.