FDA 483 - Laboratorios Dr. Collado S.A. - April 21, 2023

Laboratorios Dr. Collado S.A. in Santo Domingo Norte was inspected and cited for significant deficiencies across its manufacturing operations. The inspection revealed inadequate laboratory controls, including a lack of specifications and testing for ingredients and microorganisms, uncontrolled laboratory records, and failures in data integrity. Additionally, the firm did not follow validated production procedures, failed to investigate discrepancies, had insufficient qualified personnel, and lacked continuous cGMP training.