Investigator Details
Amatul H Marium
Investigation Details
Last Issued Date:
September 19, 2023
Conversion Rate:
0
No. of 483’s Issued :
1
Warning Letters Issued:
0
Detailed Analysis
Approach:
Amatul H Marium''s approach prioritizes thorough documentation review, material testing, and quality control procedures. They meticulously examine the processes related to in-process materials, labeling and packaging, and equipment cleanliness. They also place emphasis on written procedures and responsibilities within the Quality Control Unit.
Profile:
Amatul H Marium is a detail-oriented FDA auditor who focuses on documentation, quality control procedures, and material testing. They prioritize thorough review and approval processes, in-process material testing, sampling and testing of labeling and packaging materials, equipment cleanliness, and written procedures for the Quality Control Unit.
Top Process Types:
- Document Management
- Contamination Control
- Deviations
- Equipment Cleaning
- Equipment Qualification
Facility Name
Product Type
483 Analysis
Converted
Warning Letter
InvaGen Pharmaceuticals, Inc.
Drugs
