Form FDA 483 · Issued 2026-03-20
SGS North America Inc. — FDA Form 483 Analysis
FEI: 1418028 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Contract Testing Laboratory) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to SGS North America Inc. (FEI 1418028) on 2026-03-20 following an inspection of its contract testing laboratory operations in Illinois. The report documents 2 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Incoming Ingredient Identity Testing & COA Qualification.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · FDCA 582(b)(4)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Systems in place to comply with verification requirements
Inspector Observation Language: "Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA. Specifically, observed during inspection of SGS North America Inc. on 2026-03-20."
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 211.84(b)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Representative Samples
Inspector Observation Language: "Representative samples are not taken of each shipment of each lot of [components] [drug product containers] [closures] for testing or examination. Specifically, observed during inspection of SGS North America Inc. on 2026-03-20."
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.