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Global FDA Facility Graph & Co-Packer Intelligence
Facility Graph → Medical Devices → Brookfield Medical Surgical Supplies Inc
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Medical Devices FEI: 3011430551 🛡️ LEVEL 1 · ACTIVE REMEDIATION REQUIRED

Brookfield Medical Surgical Supplies Inc

Registered Address: Connecticut, United States (United States)

For Brand Buyers: Brookfield Medical Surgical Supplies Inc carries a CCC (42/100) 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: Brookfield Medical Surgical Supplies Inc
CCC
42/100
Elevated Citations
7-Dim FDA Record Index v2.0
More recent FDA citations than 80% of tracked Medical Devices facilities.
Based strictly on public U.S. FDA records as of 2026-11-03. See Formula v2.0
Dim 1 · Credit Grade
CCC (42/100)
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
9 Brands
~40 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3011430551's FDA Record

5 Questions to Ask Brookfield Medical Surgical Supplies 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 2026-07-10, FDA cited 21 CFR 820.30(a) (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 2026-07-10, FDA cited 21 CFR 820.30(g) (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: On 2026-07-10, FDA cited 21 CFR 820.40 (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?
  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 3011430551?

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 · 2026-07-10
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Brookfield Medical Surgical Supplies Inc (FEI 3011430551) on 2026-07-10 following an inspection of its outsourcing facility operations in Connecticut. The report documents 5 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems.

  • 21 CFR 820.30(a) (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. REPEAT OBSERVATION
  • 21 CFR 820.30(g) (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.
  • 21 CFR 820.40 (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 820.72(a) (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.
  • 21 CFR 820.50(a) (Supplier Qualification & Foreign Supplier Verification (FSVP)): Failure to develop or maintain a Foreign Supplier Verification Program (FSVP) or approved vendor qualification file verifying that raw material suppliers meet U.S. FDA safety standards.
FDA Warning Letter (CMS-684115) · 2025-12-10
View Warning Letter Details →
CGMP / Adulterated Medical Devices Violations (21 CFR 820.30(a), 21 CFR 820.30(g)) — 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.

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) 25/100
Materials & Incoming Identity 35/100
Production & Batch Records 44/100
Facilities, Sanitation & Pest 30/100
Laboratory & Stability Controls 43/100
Packaging & Allergen Labeling 47/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (42/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2026-07-10 -9.3 pts INSP-483-3011430551-20260710 ↗
Form 483 (5 observations, 1 repeat) 2026-07-10 -16.7 pts 483-3011430551-20260710 ↗
Warning Letter (Open) 2025-12-10 -24.4 pts CMS-684115 ↗