Form FDA 483 · Issued 2026-01-16
Marson Medical, Inc. — FDA Form 483 Analysis
FEI: 1000550978 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Contract Manufacturer) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to Marson Medical, Inc. (FEI 1000550978) on 2026-01-16 following an inspection of its contract manufacturer operations in New Jersey. The report documents 2 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.56(b)
Cleaning Validation, Sanitation Logs & Pest Control
REPEAT CITATION AT FACILITY
Written sanitation procedures lacking
Inspector Observation Language: "There is a lack of written procedures [assigning responsibility] [providing cleaning schedules] [describing in sufficient detail the methods, equipment and materials to be used] for sanitation. Specifically, observed during inspection of Marson Medical, Inc. on 2026-01-16."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.
Observation #2 · 21 CFR 211.105(a)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Identification of containers, lines, equipment
Inspector Observation Language: "All [compounding and storage containers] [processing lines] [major equipment] used during the production of a batch of drug product is not properly identified at all times to indicate [contents] [the phase of processing of the batch]. Specifically, observed during inspection of Marson Medical, Inc. on 2026-01-16."
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.