CC0 PUBLIC RECORD GRAPH Every score & timeline item links directly to its underlying U.S. FDA record (openFDA, ORA FOIA Reading Room, DECRS & OASIS).
Scoring Formula v2.0 & Legal Guardrails REST API v1
FG
GMPGraphv2.0
Global FDA Facility Graph & Co-Packer Intelligence
Facility Graph → Pharmaceuticals & Sterile/OTC Drugs → Imprimis NJOF LLC
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3013024146 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Imprimis NJOF LLC

Registered Address: New Jersey, United States (United States)

For Brand Buyers: Imprimis NJOF LLC carries a BB (68/100) rating due to documented FDA activity centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention. Before wiring a deposit, require written proof of CAPA closure and third-party ISO 17025 finished-batch release testing.
Connected FDA Sources (2): FDA ORA FOIA Electronic Reading Room, FDA Warning Letters Archive · Resolved Name Aliases: Imprimis NJOF LLC
BB
68/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 25th 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
BB (68/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
76%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
30%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
11 Brands
~52 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3013024146's FDA Record

5 Questions to Ask Imprimis NJOF 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 2026-08-18, FDA cited 21 CFR 211.113(b) (Electronic Record Data Integrity (21 CFR Part 11) & Retention). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  2. Q2: On 2026-08-18, FDA cited 21 CFR 211.113(b) (Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  3. Q3: 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?
  4. Q4: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI 3013024146?
  5. Q5: Can we review a redacted Master Manufacturing Record (MMR) and Batch Production Record (BPR) with dual-operator weight verification and yield reconciliation?

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 · 2026-08-18
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Imprimis NJOF LLC (FEI 3013024146) on 2026-08-18 following an inspection of its outsourcing facility operations in New Jersey. The report documents 2 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems.

  • 21 CFR 211.113(b) (Electronic Record Data Integrity (21 CFR Part 11) & Retention): Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
  • 21 CFR 211.113(b) (Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems): Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
FDA Warning Letter (CMS-684108) · 2026-07-15
View Warning Letter Details →
CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.113(b), 21 CFR 211.113(b)) — Status: Closed Out (FDA Closeout Letter Issued)

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.

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) 63/100
Materials & Incoming Identity 69/100
Production & Batch Records 70/100
Facilities, Sanitation & Pest 64/100
Laboratory & Stability Controls 69/100
Packaging & Allergen Labeling 73/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (68/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2026-08-18 -9.5 pts INSP-483-3013024146-20260818 ↗
Form 483 (2 observations, 0 repeat) 2026-08-18 -5.7 pts 483-3013024146-20260818 ↗
Warning Letter (Closed Out) 2026-07-15 -9.3 pts CMS-684108 ↗