Form FDA 483 · Issued 2025-09-16
Fareva Amboise — FDA Form 483 Analysis
FEI: 3000234005 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Sterile Drug Manufacturer) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to Fareva Amboise (FEI 3000234005) on 2025-09-16 following an inspection of its sterile drug manufacturer operations in France. 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 211.170(b)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Drug product reserve containers
Inspector Observation Language: "Drug product reserve samples are not stored in [the same immediate container-closure system as the marketed product] [an immediate container-closure system that has essentially the same characteristics as the marketed product]. Specifically, observed during inspection of Fareva Amboise on 2025-09-16."
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 211.110(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Control procedures fail to include the following
Inspector Observation Language: "Control procedures fail to include [tablet or capsule weight variation] [disintegration time] [adequacy of mixing to assure uniformity and homogeneity] [dissolution time and rate] [clarity, completeness or pH of solutions]. Specifically,observed during inspection of Fareva Amboise on 2025-09-16."
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.