Form FDA 483 · Issued 2026-09-10
Victory Medical Center Pharmacy — FDA Form 483 Analysis
FEI: 3010485868 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Producer of Sterile and Non Sterile Drug Products) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Victory Medical Center Pharmacy (FEI 3010485868) on 2026-09-10 following an inspection of its producer of sterile and non sterile drug products operations in Texas. 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 · 21 CFR 211.22(d)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Procedures not in writing, fully followed
Inspector Observation Language: "The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, observed during inspection of Victory Medical Center Pharmacy on 2026-09-10."
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 211.160(b)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Scientifically sound laboratory controls
Inspector Observation Language: "Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to appropriate standards of identity, strength, quality and purity. Specifically, observed during inspection of Victory Medical Center Pharmacy on 2026-09-10."
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.