Form FDA 483 · Issued 2026-02-20
BURTON MEDICAL — FDA Form 483 Analysis
FEI: 3009542956 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Manufacturer) · Lead Investigator: Elena R. Rostova
FDA Form 483 issued to BURTON MEDICAL (FEI 3009542956) on 2026-02-20 following an inspection of its manufacturer operations in Illinois. 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 211.167(c)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Controlled release dosage form testing
Inspector Observation Language: "Each batch of controlled-release dosage form drug product is not laboratory tested to determine conformance to the specifications for the rate of release for each active ingredient. Specifically, observed during inspection of BURTON MEDICAL on 2026-02-20."
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 211.65(a)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Equipment construction - reactive surfaces
Inspector Observation Language: "Equipment surfaces that contact [components] [in-process materials] [drug products] are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. Specifically, observed during inspection of BURTON MEDICAL on 2026-02-20."
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 211.165(c)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Sampling and testing plans not followed
Inspector Observation Language: "Written procedures for sampling and testing plans are not followed for each drug product. Specifically, observed during inspection of BURTON MEDICAL on 2026-02-20."
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.