Form FDA 483 · Issued 2026-03-27
Revive Rx LLC — FDA Form 483 Analysis
FEI: 3016710945 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Producer of Sterile and Non Sterile Drug Products) · Lead Investigator: Elena R. Rostova
FDA Form 483 issued to Revive Rx LLC (FEI 3016710945) on 2026-03-27 following an inspection of its producer of sterile and non sterile drug products operations in Texas. The report documents 3 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Incoming Ingredient Identity Testing & COA Qualification.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.166(b)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Adequate number of batches on stability
Inspector Observation Language: "An adequate number of batches of each drug product are not tested [nor are records of such data maintained] to determine an appropriate expiration date. Specifically, observed during inspection of Revive Rx LLC on 2026-03-27."
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 211.84(d)(2)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Testing Each Component for Conformity with Specs
Inspector Observation Language: "Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality. Specifically, observed during inspection of Revive Rx LLC on 2026-03-27."
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.
Observation #3 · 21 CFR 211.192
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Quality control unit review of records
Inspector Observation Language: "Drug product production and control records, are not [reviewed] [approved] by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Specifically, observed during inspection of Revive Rx LLC on 2026-03-27."
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.