Form FDA 483 · Issued 2025-09-10
Center for Assisted Reproduction — FDA Form 483 Analysis
FEI: 3003926882 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Reproductive Human Tissue) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Center for Assisted Reproduction (FEI 3003926882) on 2025-09-10 following an inspection of its reproductive human tissue operations in Texas. The report documents 2 inspection observations centered on Label Control, Undeclared Allergens & Structure/Function Claims, Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.122(a)
Label Control, Undeclared Allergens & Structure/Function Claims
FIRST-TIME OBSERVATION
Written procedures not followed
Inspector Observation Language: "Written procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of packaging and labeling materials are not followed. Specifically, observed during inspection of Center for Assisted Reproduction on 2025-09-10."
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 211.160(b)(3)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Drug products-sampling procedures/specifications
Inspector Observation Language: "Laboratory controls do not include a determination of conformance to [written descriptions of sampling procedures] [appropriate specifications] for drug products. Specifically, observed during inspection of Center for Assisted Reproduction on 2025-09-10."
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.