FDA 483 - Merck, S.A. de C.V. - April 08, 2022

Merck, S.A. de C.V. in Naucalpan De Juarez, Mexico, was issued a Form 483 with two observations following an FDA inspection. The firm's quality control unit was cited for not adhering to written procedures, including issues with analytical method updates, complaint investigations, electronic batch records, and out-of-specification investigations. Additionally, the inspection found that records for equipment sanitization were not properly maintained, specifically regarding incomplete sanitization alarms.