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GMPGraphv2.0
Global FDA Facility Graph & Co-Packer Intelligence
Facility Graph → Pharmaceuticals & Sterile/OTC Drugs → OSRX Inc
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3014549846 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

OSRX Inc

Registered Address: Montana, United States (United States)

For Brand Buyers: OSRX Inc carries a BBB (70/100) rating due to documented FDA activity centered on Master Manufacturing & Batch Production Records (MMR/BPR). Before wiring a deposit, require written proof of CAPA closure and third-party ISO 17025 finished-batch release testing.
Connected FDA Sources (1): FDA ORA FOIA Electronic Reading Room · Resolved Name Aliases: OSRX Inc
BBB
70/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 36th percentile among Pharmaceuticals & Sterile/OTC Drugs facilities.
Based strictly on public U.S. FDA records as of 2026-11-03. See Formula v2.0
Dim 1 · Credit Grade
BBB (70/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
68%
MODERATE CYCLE WINDOW (6–12 Months)
Dim 5 · 180d WL Escalation
67%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
6 Brands
~25 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3014549846's FDA Record

5 Questions to Ask OSRX Inc Before Signing a Manufacturing Contract

Bring these exact questions to your discovery call with their QA Director or account rep before wiring a production deposit:

  1. Q1: On 2025-11-14, FDA cited 21 CFR 211.134(a) (Label Control, Undeclared Allergens & Structure/Function Claims). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  2. Q2: On 2025-11-14, FDA cited 21 CFR 211.80(d) (Incoming Ingredient Identity Testing & COA Qualification). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  3. Q3: On 2025-11-14, FDA cited 21 CFR 211.165(c) (Master Manufacturing & Batch Production Records (MMR/BPR)). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  4. Q4: Do you perform 100% FTIR/HPLC identity testing on incoming active ingredients in-house (21 CFR 111.75(a)(1)), or do you rely on vendor COAs?
  5. Q5: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI 3014549846?

Cross-Database Regulatory & Inspection Timeline

Unified chronological history across FDA ORA Inspections, Form 483s, Warning Letters, Enforcement Recalls, and OASIS Import Refusals.

Form FDA 483 Issued · 2025-11-14
Open Full 483 Analysis & Dossier →

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.

  • 21 CFR 211.134(a) (Label Control, Undeclared Allergens & Structure/Function Claims): Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
  • 21 CFR 211.80(d) (Incoming Ingredient Identity Testing & COA Qualification): 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.
  • 21 CFR 211.165(c) (Master Manufacturing & Batch Production Records (MMR/BPR)): Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification. REPEAT OBSERVATION
  • 21 CFR 211.182 (Cleaning Validation, Sanitation Logs & Pest Control): Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
  • 21 CFR 211.188(b)(10) (Master Manufacturing & Batch Production Records (MMR/BPR)): Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.

Manufacturer Right-of-Reply & Free Match Correction

GUARDRAIL PROTECTED

To ensure fairness and accuracy, facility owners may submit verified Form 483 closeout evidence, CAPA completion statements, or entity-resolution corrections free of charge. Sponsorship never alters an FDA Record Index score.

Dimension 3 · FDA 6-System Model

6-Subsystem cGMP Radar Breakdown

Sub-scores mapped across FDA's six core inspection subsystems.

Quality System (CAPA & OOS) 73/100
Materials & Incoming Identity 63/100
Production & Batch Records 50/100
Facilities, Sanitation & Pest 66/100
Laboratory & Stability Controls 71/100
Packaging & Allergen Labeling 67/100
Layer 6 · Clean-Record Sourcing Alternatives

Verified AAA/AA Co-Packers in This Sector

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Lone Star Nutraceuticals & Gummy Works LLC (TX)
Grade AAA · 99/100 Clean Record
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Score Provenance Receipts

Every point in this facility's FDA Record Index (70/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2025-11-14 -8.0 pts INSP-483-3014549846-20251114 ↗
Form 483 (5 observations, 1 repeat) 2025-11-14 -14.4 pts 483-3014549846-20251114 ↗