Form FDA 483 · Issued 2026-02-10
Ventana Medical Systems, Inc. — FDA Form 483 Analysis
FEI: 1000125183 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Manufacturer) · Lead Investigator: David K. Chen
FDA Form 483 issued to Ventana Medical Systems, Inc. (FEI 1000125183) on 2026-02-10 following an inspection of its manufacturer operations in Arizona. The report documents 4 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Personnel GMP Training, Gowning & Hygienic Practices.
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 212.71(c)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Correction of problems
Inspector Observation Language: "You did not take [appropriate] action to correct any identified problems to prevent recurrence of a nonconforming product or other quality problem. Specifically,observed during inspection of Ventana Medical Systems, Inc. on 2026-02-10."
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 · FDCA 505-1(f)(3)(A)
Personnel GMP Training, Gowning & Hygienic Practices
REPEAT CITATION AT FACILITY
Failure to comply with REMS Elements to Assure Safe Use (ETASU) A
Inspector Observation Language: "An application holder did not [ensure healthcare providers (HCPs) who prescribe the drug are specially certified] [ensure mechanisms are in place that allow healthcare providers (HCPs) the ability to complete the certification process] [secure a database of certified healthcare providers (HCPs)] [identify and address non-compliant certified healthcare providers (HCPs)] [make training available to prescribing healthcare providers (HCPs)], as required by your approved REMS Element to Assure Safe Use (ETASU) A. Specifically, observed during inspection of Ventana Medical Systems, Inc. on 2026-02-10."
Plain-English Meaning: Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
Standard CAPA Remediation Path: Maintain role-based SOP training matrices signed prior to independent floor assignment and annual cGMP refresher assessments.
Observation #3 · 21 CFR 211.105(b)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Distinctive ID or code not recorded in batch record
Inspector Observation Language: "The batch records do not record the distinctive [identification number] [code] [name of equipment] to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product. Specifically, observed during inspection of Ventana Medical Systems, Inc. on 2026-02-10."
Plain-English Meaning: Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
Standard CAPA Remediation Path: Ensure every product SKU has an approved MMR matching the exact label claim and every batch record captures raw material lot traceability, in-process weight/pH checks, and QA release signatures.
Observation #4 · 21 CFR 211.122(d)
Label Control, Undeclared Allergens & Structure/Function Claims
FIRST-TIME OBSERVATION
Labels and labeling stored separately
Inspector Observation Language: "Labels and other labeling materials are not stored separately with suitable identification for each different drug product, strength, dosage form or quantity of contents. Specifically, observed during inspection of Ventana Medical Systems, Inc. on 2026-02-10."
Plain-English Meaning: Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
Standard CAPA Remediation Path: Implement 100% barcode/vision verification on packaging lines, strict allergen matrix segregation, and regulatory review removing disease endpoints from supplement/cosmetic copy.