Kula Jha
Investigation Details
Bethany Baer , Y Nguyen , Thomas Ryan Withers , Oluchi Elekwachi , Kavita Natrajan , Peter Lenahan , Laura Fontan , Andrew Harmon , Feorillo Galivo , Natasha Thorne , Simleen Kaur , Mikhail Ovanesov , Yuqun Abigail Luo , Varsha Garnepudi , Andrey Sarafanov , Emmanuel Adu-Gyamfi , Ben Cyge , Leyish Minie , Arifa Khan , Marie Anderson , Bradley Dworak , Xiaofei Wang
483s Issues in Countries
Form 483 Issued by Year
Top 5 Sub-Systems
Top 5 Co-Investigators
Investigator Analysis
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.
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.
Form 483s Issued
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