Form FDA 483 · Issued 2026-03-05
Steven M. Wolf, M.D. — FDA Form 483 Analysis
FEI: 3042639431 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Sponsor) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Steven M. Wolf, M.D. (FEI 3042639431) on 2026-03-05 following an inspection of its sponsor operations in Nevada. The report documents 2 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), CAPA, Out-of-Specification (OOS) & Complaint Investigations.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.170(b)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
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 Steven M. Wolf, M.D. on 2026-03-05."
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 #2 · 21 CFR 211.198(a)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
REPEAT CITATION AT FACILITY
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 Steven M. Wolf, M.D. on 2026-03-05."
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.