483
APARNA ORGANICS LIMITEDAPARNA ORGANICS LIMITED – FDA 483, Sep 11, 2023
Record Details
Aparna Organics Limited, an Intermediate API Manufacturer in Chilivalasa, India, received a Form 483 with repeat observations concerning significant quality system deficiencies. The inspection revealed inadequate equipment cleaning, a lack of quality unit oversight, and insufficient controls over electronic GMP data. These issues indicate a moderate level of severity regarding the firm's adherence to good manufacturing practices.
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ID · 2f68d350-68f3-40c7-a3c7-e442203e9554
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