Form FDA 483 · Issued 2026-07-10
Brookfield Medical Surgical Supplies Inc — FDA Form 483 Analysis
FEI: 3011430551 · Sector: Medical Devices (Outsourcing Facility) · Lead Investigator: Jonathan A. Vance
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.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 820.30(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Design control - no procedures
Inspector Observation Language: "Procedures for design control have not been established. Specifically,observed during inspection of Brookfield Medical Surgical Supplies Inc on 2026-07-10."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.
Observation #2 · 21 CFR 820.30(g)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
Design validation- Lack of or inadequate procedures
Inspector Observation Language: "Procedures for design validation have not been [adequately] established. Specifically,observed during inspection of Brookfield Medical Surgical Supplies Inc on 2026-07-10."
Plain-English Meaning: Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
Standard CAPA Remediation Path: Tag all critical measuring instruments with calibration due dates, lock out overdue devices, and perform weekly TOC/conductivity/bioburden testing on purified water loops.
Observation #3 · 21 CFR 820.40
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Procedures not adequately established or maintained
Inspector Observation Language: "Document control procedures have not been adequately [established] [maintained]. Specifically,observed during inspection of Brookfield Medical Surgical Supplies Inc on 2026-07-10."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.
Observation #4 · 21 CFR 820.72(a)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Inspector Observation Language: "Procedures to ensure equipment is routinely [calibrated] [inspected] [checked] [maintained] have not been [adequately] established. Specifically, observed during inspection of Brookfield Medical Surgical Supplies Inc on 2026-07-10."
Plain-English Meaning: Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
Standard CAPA Remediation Path: Tag all critical measuring instruments with calibration due dates, lock out overdue devices, and perform weekly TOC/conductivity/bioburden testing on purified water loops.
Observation #5 · 21 CFR 820.50(a)
Supplier Qualification & Foreign Supplier Verification (FSVP)
FIRST-TIME OBSERVATION
Evaluation of suppliers, contractors, etc., requirements
Inspector Observation Language: "Requirements that must be met by [suppliers] [contractors] [consultants] have not been [adequately] established. Specifically, observed during inspection of Brookfield Medical Surgical Supplies Inc on 2026-07-10."
Plain-English Meaning: 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.
Standard CAPA Remediation Path: Maintain an Approved Supplier List (ASL) with hazard analysis, third-party GMP audit certificates, and FSVP importer identification for every foreign ingredient.