Form FDA 483 · Issued 2026-02-24
The SYGMA Network — FDA Form 483 Analysis
FEI: 3004268067 · Sector: EPA / Specialty Chemical (Importer/Warehouse/Repacker) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to The SYGMA Network (FEI 3004268067) on 2026-02-24 following an inspection of its importer/warehouse/repacker operations in California. The report documents 3 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.42(b)
Incoming Ingredient Identity Testing & COA Qualification
REPEAT CITATION AT FACILITY
Adequate space lacking to prevent mix-ups and contamination
Inspector Observation Language: "The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between [different components] [drug product containers] [closures] [labeling] [in-process materials] [drug products] and to prevent contamination. Specifically, observed during inspection of The SYGMA Network on 2026-02-24."
Plain-English Meaning: 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.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #2 · FDCA 501(a)(2)(A)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Lack of/inadequate, environmental monitoring
Inspector Observation Language: "[Lack of] [Inadequate] routine environmental monitoring in the [ISO 5 area] [classified areas]. Specifically, observed during inspection of The SYGMA Network on 2026-02-24."
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 #3 · 21 CFR 211.68(b)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
Backup file not maintained
Inspector Observation Language: "Failure to maintain a backup file of data entered into the computer or related system. Specifically, observed during inspection of The SYGMA Network on 2026-02-24."
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.