Form FDA 483 · Issued 2025-11-14
OSRX Inc — FDA Form 483 Analysis
FEI: 3014549846 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Outsourcing Facility) · Lead Investigator: Jonathan A. Vance
FDA Form 483 issued to OSRX Inc (FEI 3014549846) on 2025-11-14 following an inspection of its outsourcing facility operations in Montana. The report documents 5 inspection observations centered on Label Control, Undeclared Allergens & Structure/Function Claims, Incoming Ingredient Identity Testing & COA Qualification.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.134(a)
Label Control, Undeclared Allergens & Structure/Function Claims
FIRST-TIME OBSERVATION
Correct labels during finishing operations
Inspector Observation Language: "Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the correct label. Specifically, observed during inspection of OSRX Inc on 2025-11-14."
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.
Observation #2 · 21 CFR 211.80(d)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Identification of Each Lot in Each Shipment
Inspector Observation Language: "Each lot in each shipment received was not identified with a distinctive code for each container or grouping of containers for [components] [drug product containers] [closures]. Specifically, observed during inspection of OSRX Inc on 2025-11-14."
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)
Master Manufacturing & Batch Production Records (MMR/BPR)
REPEAT CITATION AT FACILITY
Sampling and testing plans not described
Inspector Observation Language: "Sampling and testing plans for drug products are not described in written procedures which include the [method of sampling] [number of units per batch to be tested]. Specifically, observed during inspection of OSRX Inc on 2025-11-14."
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 #4 · 21 CFR 211.182
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Personnel dating/signing equipment log
Inspector Observation Language: "The persons [performing] [double-checking] the cleaning and maintenance are not [dating] [signing or initialing] the equipment cleaning and use log. Specifically, observed during inspection of OSRX Inc on 2025-11-14."
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 #5 · 21 CFR 211.188(b)(10)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Documentation of Sampling Performed
Inspector Observation Language: "The batch production and control records are deficient in that they do not include documentation of sampling performed. Specifically, observed during inspection of OSRX Inc on 2025-11-14."
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.