Investigator Details
Emnet Yitbarek
Investigation Details
Last Issued Date
May 31, 2024
No. of 483’s Issued
since 2023
1
Warning Letters Issued
0
Detailed Analysis
Approach:
Emnet Yitbarek prioritizes scrutinizing GMP compliance in drug manufacturing, particularly focusing on production and process controls and quality control testing. He looks for systemic issues that could impact product safety and efficacy.
Profile:
Emnet Yitbarek is a detail-oriented FDA investigator with a focus on GMP compliance in drug substance and drug product manufacturing. He is particularly concerned about production and process controls, standard manufacturing protocols, and quality control testing for drug products.
Top Process Types:
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