FDA 483 - Talbot's Pharmaceuticals Family Products, LLC - February 14, 2019

Talbot's Pharmaceuticals Family Products, LLC, a manufacturer in Monroe, LA, was inspected by the FDA from February 12-14, 2019. The inspection revealed significant deficiencies in the firm's quality control unit, specifically regarding the failure to follow established procedures for auditing manufacturers, retaining product samples, and reviewing inspection reports as outlined in their quality agreements. These findings indicate a lack of adherence to critical quality control responsibilities.