FDA 483 - Groupe Parima Inc. - January 24, 2020
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Groupe Parima Inc., an OTC drug manufacturer in Saint-Laurent, received an FDA Form 483 citing multiple deficiencies in its quality control and laboratory operations. Observations include inadequate laboratory test procedures, incomplete data records, failure to follow quality control and complaint management procedures, unvalidated computer systems, and issues with equipment calibration and supplier qualification. These findings indicate significant gaps in the firm's adherence to cGMP regulations.
ID · 586024ac-2f77-4e9d-8c0a-bccdb6402e6c