483
Swati Spentose Private LimitedSwati Spentose Private Limited – FDA 483, May 31, 2024
Record Details
Swati Spentose Private Limited, an API Non-Sterile Drug Substance Manufacturer in Vapi, India, was cited with two observations during an FDA inspection. The inspection revealed significant deficiencies in employee training, specifically for QC laboratory reviewers, and a systemic failure within the quality control unit to follow approved testing procedures, leading to a high number of recurring human errors.
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