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Navigate 483 Signal's library of FDA inspection analysis organized by content type, issue category, and facility type.
Content Types
483 Analysis
Weekly breakdowns of Form 483 observations from an operator perspective.
View all →Warning Letters
Deep dives into serious violations and enforcement patterns.
View all →Trend Reports
Quarterly analysis of FDA inspection patterns and emerging trends.
View all →Case Studies
Long-form tracking of facilities through FDA enforcement actions.
View all →Common Issues
Data Integrity
ALCOA violations, audit trails, data manipulation, and electronic records issues.
View all →Aseptic Processing
Sterility failures, contamination control, cleanroom violations, and media fills.
View all →Validation & Qualification
Process validation, cleaning validation, and equipment qualification issues.
View all →Laboratory Controls
OOS investigations, method validation, and analytical testing failures.
View all →Equipment & Facilities
Equipment qualification, maintenance, calibration, and facility design issues.
View all →Documentation & Records
GMP documentation, batch records, SOPs, and record-keeping violations.
View all →CAPA & Quality Systems
Corrective action, preventive action, and quality management system issues.
View all →Supply Chain & Materials
Supplier qualification, raw materials testing, and component controls.
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