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483
•V-Ensure Pharma Technologies Pvt. Limited•January 27, 2023

V-Ensure Pharma Technologies Pvt. Limited – FDA 483, Jan 27, 2023

Record Details

V-Ensure Pharma Technologies Pvt. Limited in Raigad, India, was issued a Form 483 following an FDA inspection from January 23-27, 2023. The inspection revealed a significant quality system deficiency related to the firm's failure to investigate and document unexplained discrepancies in manufacturing records. This indicates a serious lapse in the firm's quality control and record-keeping practices for drug manufacturing.

Company
V-Ensure Pharma Technologies Pvt. Limited
Inspection date
January 27, 2023
Product type
drugs
Office
Office of Biological Products Operations - Division I
Person
  • Ucheabuchi C. Chudi-Nwankwor
View Company Profile

ID · f40e8805-b189-49dc-a34c-d7be69837328

Other documents for V-Ensure Pharma Technologies Pvt. Limited
  • 483 - 2024-05-17May 17, 2024

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