483
Lofty Laboratories Private LimitedLofty Laboratories Private Limited – FDA 483, Aug 4, 2022
Record Details
An FDA inspection of Lofty Laboratories Private Limited in Pashamylaram, India, revealed significant deficiencies in laboratory controls and quality systems. The firm failed to adequately investigate unexplained discrepancies, including HPLC system suitability failures and column leakages. Additionally, their HPLC test methods for intermediate drug substances lacked established system suitability runs prior to analysis.
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ID · 701429d4-ee2a-4c36-963c-f6b95639f261
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