Investigator Details
Barbara Wilimczyk Macri
Investigation Details
Last Issued Date
March 24, 2023
No. of 483’s Issued
since 2023
1
Warning Letters Issued
0
Detailed Analysis
Approach:
Barbara Wilimczyk Macri meticulously scrutinizes environmental and cleaning conditions, control over materials and products, investigation procedures, testing methods, laboratory records, specifications, and expiration dating practices during inspections.
Profile:
Barbara Wilimczyk Macri is a detail-oriented FDA auditor who places high importance on environmental conditions, cleaning procedures, warehousing systems, investigation of deviations, test method validity, laboratory control, specifications, and expiration dating in pharmaceutical facilities.
Top Process Types:
- Document Management
- Environmental Monitoring
- Laboratory Controls
- Batch Records
- Cleaning Validation
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