483
JPR Labs Private LimitedFDA 483 - JPR Labs Private Limited - September 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