Form FDA 483 · Issued 2026-02-23
Misemer Pharmaceutical, Inc. — FDA Form 483 Analysis
FEI: 3016439754 · Sector: EPA / Specialty Chemical (Own Label Distributor/Repackager/Relabeler) · Lead Investigator: Elena R. Rostova
FDA Form 483 issued to Misemer Pharmaceutical, Inc. (FEI 3016439754) on 2026-02-23 following an inspection of its own label distributor/repackager/relabeler operations in Mississippi. The report documents 3 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Cleaning Validation, Sanitation Logs & Pest Control.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.25(b)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Supervisor Training/Education/Experience
Inspector Observation Language: "Individuals responsible for supervising the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess. Specifically, observed during inspection of Misemer Pharmaceutical, Inc. on 2026-02-23."
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 211.42(c)(10)(i)
Cleaning Validation, Sanitation Logs & Pest Control
REPEAT CITATION AT FACILITY
Floors, walls, ceiling surfaces
Inspector Observation Language: "Aseptic processing areas are deficient in that [floors] [walls] [ceilings] are not smooth and/or hard surfaces that are easily cleanable. Specifically,observed during inspection of Misemer Pharmaceutical, Inc. on 2026-02-23."
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 #3 · 21 CFR 211.122(a)
Label Control, Undeclared Allergens & Structure/Function Claims
FIRST-TIME OBSERVATION
Sampling/testing of labeling/packaging materials
Inspector Observation Language: "Labeling and packaging materials are not [representatively sampled] [examined] [tested] upon receipt and before use in packaging and labeling of a drug product. Specifically, observed during inspection of Misemer Pharmaceutical, Inc. on 2026-02-23."
Plain-English Meaning: Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
Standard CAPA Remediation Path: Implement 100% barcode/vision verification on packaging lines, strict allergen matrix segregation, and regulatory review removing disease endpoints from supplement/cosmetic copy.