Investigator Details
Kula Jha
Investigation Details
Last Issued Date:
June 29, 2023
Conversion Rate:
0
No. of 483’s Issued :
2
Warning Letters Issued:
0
Detailed Analysis
Approach:
Kula Jha''s approach involves meticulously reviewing documentation related to document management and process validation. They prioritize accuracy, specificity, and thoroughness in the procedures and validation documentation they inspect.
Profile:
Kula Jha is a detail-oriented FDA investigator who places a strong emphasis on document management and process validation. They are particularly concerned with the accuracy and specificity of procedures, especially related to the use and handling of product contacting materials, WFI, and facility cleaning. Additionally, they prioritize thorough and detailed documentation of process validation, especially in terms of specific time storage of products within the manufacturing facility and storage conditions.
Top Process Types:
- Document Management
- Process Validation
