Form FDA 483 · Issued 2026-03-06
Aurorium LLC — FDA Form 483 Analysis
FEI: 1628757 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Producer of Regulated Products) · Lead Investigator: David K. Chen
FDA Form 483 issued to Aurorium LLC (FEI 1628757) on 2026-03-06 following an inspection of its producer of regulated products operations in Texas. The report documents 4 inspection observations centered on Personnel GMP Training, Gowning & Hygienic Practices, Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 211.122(d)
Personnel GMP Training, Gowning & Hygienic Practices
FIRST-TIME OBSERVATION
Label storage access limited to authorized personnel
Inspector Observation Language: "Access to the storage area for labels and labeling materials is not limited to authorized personnel. Specifically, observed during inspection of Aurorium LLC on 2026-03-06."
Plain-English Meaning: Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
Standard CAPA Remediation Path: Maintain role-based SOP training matrices signed prior to independent floor assignment and annual cGMP refresher assessments.
Observation #2 · 21 CFR 211.194(a)(2)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Laboratory Test Method Verification
Inspector Observation Language: "Verification of the suitability of the testing methods is deficient in that they are not [performed under actual conditions of use] [documented on the laboratory records]. Specifically, observed during inspection of Aurorium LLC on 2026-03-06."
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 #3 · 21 CFR 211.170(b)
Master Manufacturing & Batch Production Records (MMR/BPR)
REPEAT CITATION AT FACILITY
Reserve samples identified, representative, stored
Inspector Observation Language: "Reserve drug product samples are not [appropriately identified] [representative of each lot or batch of drug product] [retained and stored under conditions consistent with product labeling]. Specifically, observed during inspection of Aurorium LLC on 2026-03-06."
Plain-English Meaning: Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
Standard CAPA Remediation Path: Ensure every product SKU has an approved MMR matching the exact label claim and every batch record captures raw material lot traceability, in-process weight/pH checks, and QA release signatures.
Observation #4 · 21 CFR 211.198(a)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Procedures to be written and followed
Inspector Observation Language: "Procedures describing the handling of all written and oral complaints regarding a drug product are not [established] [written] [followed]. Specifically, observed during inspection of Aurorium LLC on 2026-03-06."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.