Form 483 Library → Catholic Health Initiatives Institute for Research and Innovation IRB → 483-3013827563-20260303
Form FDA 483 · Issued 2026-03-03
Catholic Health Initiatives Institute for Research and Innovation IRB — FDA Form 483 Analysis
FEI: 3013827563 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Institutional Review Board) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Catholic Health Initiatives Institute for Research and Innovation IRB (FEI 3013827563) on 2026-03-03 following an inspection of its institutional review board operations in Colorado. The report documents 2 inspection observations centered on Label Control, Undeclared Allergens & Structure/Function Claims, Incoming Ingredient Identity Testing & COA Qualification.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.130
Label Control, Undeclared Allergens & Structure/Function Claims
FIRST-TIME OBSERVATION
Procedures are written, and followed
Inspector Observation Language: "Procedures designed to assure that correct [labels] [labeling] [packaging materials] are used for drug products are not [written] [followed]. Specifically, observed during inspection of Catholic Health Initiatives Institute for Research and Innovation IRB on 2026-03-03."
Plain-English Meaning: Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
Standard CAPA Remediation Path: Implement 100% barcode/vision verification on packaging lines, strict allergen matrix segregation, and regulatory review removing disease endpoints from supplement/cosmetic copy.
Observation #2 · 21 CFR 211.84(e)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Rejecting When Specifications Not Met
Inspector Observation Language: "Failure to reject any lot of [components] [drug product containers] [closures] that did not meet the appropriate written specifications for identity, strength, quality, and purity. Specifically, observed during inspection of Catholic Health Initiatives Institute for Research and Innovation IRB on 2026-03-03."
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.