Form FDA 483 · Issued 2026-04-14
Biomat USA Inc — FDA Form 483 Analysis
FEI: 3014028128 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Source Plasma Establishment) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Biomat USA Inc (FEI 3014028128) on 2026-04-14 following an inspection of its source plasma establishment operations in Texas. The report documents 2 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 212.20(e)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Written QA procedures established, followed
Inspector Observation Language: "You did not [establish] [follow] written quality assurance procedures. Specifically,observed during inspection of Biomat USA Inc on 2026-04-14."
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 211.22(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Authority lacking to review records, investigate errors
Inspector Observation Language: "The quality control unit lacks authority to [review production records to assure that no errors have occurred] [fully investigate errors that have occurred]. Specifically, observed during inspection of Biomat USA Inc on 2026-04-14."
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.