Lupin Research IncFebruary 19, 2020

FDA 483 - Lupin Research Inc - February 19, 2020

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Record Details

Lupin Research Inc. in Coral Springs, FL, was cited with two observations during an FDA inspection of its inhalation drug product manufacturing. The firm's batch production and control records were found to be incomplete, lacking essential documentation for critical process parameters and product information. Additionally, the quality control unit failed to adequately review the completeness of executed batch production records for validation batches.

Company: Lupin Research Inc
Inspection Date: February 19, 2020
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Dennis Cantellops Paite

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ID · de85d291-8556-41e0-8dc7-0a682b52a18c