Form FDA 483 · Issued 2025-12-12
Pure Indulgence Aesthetics — FDA Form 483 Analysis
FEI: 3041017461 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Dispenser of Prescription Drugs) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Pure Indulgence Aesthetics (FEI 3041017461) on 2025-12-12 following an inspection of its dispenser of prescription drugs operations in United States. The report documents 2 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 212.60(g)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Test records complete (general)
Inspector Observation Language: "Each laboratory used to perform tests related to the production of a PET drug did not keep complete records of all tests performed to ensure compliance with established specifications and standards, including examinations and assays. Specifically,observed during inspection of Pure Indulgence Aesthetics on 2025-12-12."
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 · FDCA 501(a)(2)(A)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Contamination, production area/adjacent areas
Inspector Observation Language: "Contamination was observed in your [production area] [areas adjacent to production areas]. Specifically, observed during inspection of Pure Indulgence Aesthetics on 2025-12-12."
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.