Investigator Details
Bijoy Panicker
Investigation Details
Last Issued Date:
September 19, 2023
Conversion Rate:
0
No. of 483’s Issued :
3
Warning Letters Issued:
0
Detailed Analysis
Approach:
Bijoy Panicker takes a systematic approach, meticulously reviewing procedures, testing methods, and documentation. He expects clear and well-defined processes and thorough record-keeping. He focuses on ensuring the safety and quality of products through rigorous testing and quality control procedures.
Profile:
Bijoy Panicker is a detail-oriented FDA auditor who places a strong emphasis on the quality assurance processes and procedures. He is particularly interested in the thorough testing and approval of materials, as well as the cleanliness and maintenance of equipment. He expects clear and well-defined procedures for quality control and is meticulous about documentation and record-keeping.
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
