Form FDA 483 · Issued 2026-03-19
Viant San Antonio, Inc. — FDA Form 483 Analysis
FEI: 3003640911 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Manufacturer) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Viant San Antonio, Inc. (FEI 3003640911) on 2026-03-19 following an inspection of its manufacturer operations in Texas. The report documents 2 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, CAPA, Out-of-Specification (OOS) & Complaint Investigations.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.42(c)(5)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Mfg / Processing Operations Area
Inspector Observation Language: "Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations. Specifically, observed during inspection of Viant San Antonio, Inc. on 2026-03-19."
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 211.198(b)(2)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Complaint Investigation/Follow-Up Findings
Inspector Observation Language: "Complaint records are deficient in that they do not include the findings of the [investigation] [follow-up]. Specifically, observed during inspection of Viant San Antonio, Inc. on 2026-03-19."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.