483
Vimta Labs LimitedVimta Labs Limited – FDA 483, Nov 7, 2025
Record Details
During an inspection of Vimta Labs, Ltd., a bioanalytical facility in Shameerpet, Hyderabad, FDA investigators observed a deficiency in method validation documentation. A robustness experiment, which failed acceptance criteria, was not included in a PSD method validation report. This indicates a potential issue with data integrity and proper reporting of validation studies.
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ID · d41880a2-378e-40af-a20b-daeca02a87f4
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