Form FDA 483 · Issued 2026-03-06
Dxn Pharmaceutical Sdn Bhd — FDA Form 483 Analysis
FEI: 3006649152 · Sector: Dietary Supplements (Dietary Supplement Manufacturer) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to Dxn Pharmaceutical Sdn Bhd (FEI 3006649152) on 2026-03-06 following an inspection of its dietary supplement manufacturer operations in Malaysia. The report documents 3 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 111.75(a)(2)(ii)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Reliance on supplier Certificate of Analysis (COA) without qualifying the supplier
Inspector Observation Language: "Your firm relied on a certificate of analysis from a component supplier to confirm the identity of components without first establishing the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier's tests or examinations."
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 #2 · 21 CFR 111.75(c)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Failure to verify finished dietary supplement batch meets product specifications
Inspector Observation Language: "Your firm failed to verify, for a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan, or for every finished batch, that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, and composition."
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 111.205(a)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Failure to prepare and follow a written Master Manufacturing Record (MMR)
Inspector Observation Language: "Your firm failed to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch."
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.