483
JPR Labs Private LimitedJPR Labs Private Limited – FDA 483, Sep 16, 2022
Record Details
An FDA inspection of JPR Labs Private Limited, an API-Intermediate Manufacturer in Paravada, India, revealed significant deficiencies. These included the permanent loss of historic electronic laboratory data, inadequate review of deviation investigations, and poor maintenance of equipment leading to contamination risks. Additionally, written procedures for preventative maintenance were found to be deficient or not followed.
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ID · a4927aa8-1d5b-4d2a-a66f-8c5ae23425bc
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