CC0 PUBLIC RECORD GRAPH Every score & timeline item links directly to its underlying U.S. FDA record (openFDA, ORA FOIA Reading Room, DECRS & OASIS).
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GMPGraphv2.0
Global FDA Facility Graph & Co-Packer Intelligence
Facility Graph → Pharmaceuticals & Sterile/OTC Drugs → Jubilant HollisterStier LLC
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3010477 🛡️ LEVEL 1 · ACTIVE REMEDIATION REQUIRED

Jubilant HollisterStier LLC

Registered Address: Washington, USA (USA)

For Brand Buyers: Jubilant HollisterStier LLC carries a CCC (34/100) rating due to documented FDA activity centered on Finished Product Testing, Stability & Expiration Dating. Before wiring a deposit, require written proof of CAPA closure and third-party ISO 17025 finished-batch release testing.
Connected FDA Sources (3): FDA ORA FOIA Electronic Reading Room, FDA Warning Letters Archive, FDA OASIS Import Refusals · Resolved Name Aliases: Jubilant HollisterStier LLC
CCC
34/100
Elevated Citations
7-Dim FDA Record Index v2.0
More recent FDA citations than 98% of tracked 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
CCC (34/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 1 / 4
Official Action Indicated (OAI) or Open Warning Letter
Dim 4 · 'Elsa' Audit Odds
89%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
92%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
32 Brands
~135 Downstream SKUs
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VERIFIED CONTRACT MANUFACTURER / CO-PACKER

Co-Packing Capabilities, Minimums & Certifications

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Contract pharmaceuticals & sterile/otc drugs manufacturing in WA.

Minimum Run (MOQ)5,000 units
Typical Turnaround6–10 weeks
In-House Analytical LabYes (FTIR/HPLC/Micro)
Turnkey R&D FormulationAvailable
Dosage & Product Formats:
Contract PackagingFormulationBatch Blending
Registrations & Quality Certifications:
FDA Registered Establishment
LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3010477's FDA Record

5 Questions to Ask Jubilant HollisterStier LLC 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 2026-06-17, FDA cited 21 CFR 211.166(a)(3) (Finished Product Testing, Stability & Expiration Dating). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  2. Q2: On 2026-06-17, FDA cited 21 CFR 211.25(a) (Personnel GMP Training, Gowning & Hygienic Practices). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  3. Q3: On 2026-06-17, FDA cited 21 CFR 211.100(b) (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 3010477?

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 · 2026-06-17
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Jubilant HollisterStier LLC (FEI 3010477) on 2026-06-17 following an inspection of its drug manufacturer operations in Washington. The report documents 4 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Personnel GMP Training, Gowning & Hygienic Practices.

  • 21 CFR 211.166(a)(3) (Finished Product Testing, Stability & Expiration Dating): 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.
  • 21 CFR 211.25(a) (Personnel GMP Training, Gowning & Hygienic Practices): Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
  • 21 CFR 211.100(b) (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 211.142(b) (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.
FDA Warning Letter (CMS-684118) · 2026-07-15
View Warning Letter Details →
CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.166(a)(3), 21 CFR 211.25(a)) — Status: Open — Awaiting Verified Remediation Closeout

FDA Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.

OASIS Border Import Refusal (OASIS-2026-88100) · 2026-01-19
Port: Los Angeles / Long Beach, CA · Charge: FILTH / INSANITARY CONDITIONS (FD&C Act 402(a)(4))
The article appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth.

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) 37/100
Materials & Incoming Identity 27/100
Production & Batch Records 24/100
Facilities, Sanitation & Pest 38/100
Laboratory & Stability Controls 27/100
Packaging & Allergen Labeling 39/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (34/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2026-06-17 -9.2 pts INSP-483-3010477-20260617 ↗
Form 483 (4 observations, 1 repeat) 2026-06-17 -13.7 pts 483-3010477-20260617 ↗
Warning Letter (Open) 2026-07-15 -28.0 pts CMS-684118 ↗
Import Refusal (FILTH / INSANITARY CONDITIONS) 2026-01-19 -6.7 pts OASIS-2026-88100 ↗