Investigator Details
Kemejumaka N Opara
Investigation Details
Last Issued Date:
April 20, 2022
Conversion Rate:
100
No. of 483’s Issued :
1
Warning Letters Issued:
1
Detailed Analysis
Approach:
Kemejumaka N Opara's approach, from the past audits, leans more towards detail-oriented meticulousness. He fundamentally prioritizes adherence to standard procedures, documentation integrity and regulatory compliance.
Profile:
Kemejumaka N Opara, based on the past 483 inspections, seems to exhibit a strong emphasis on microbial detection, process validation, consistency in records maintenance, and use of approved drug substances. He is likely to be rigorous in reviewing any microbiological and aseptic practices, as well as compliance with FDA-sanctioned list of bulk drug substances. His response to discrepancies and gaps in procedures or documentation appears to be thorough and strict.
Top Process Types:
- Document Management
- Investigations
- Compliance Management
- Material Receipt and Handling
- Media Fill
Facility Name
Product Type
483 Analysis
Converted
Warning Letter
Nephron Sterile Compounding Center LLC
Drugs
