FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

FDA Slams Mexican Manufacturer for Numerous Violations

Sept. 12, 2018

The FDA hit Guadalajara, Jalisco-based drug manufacturer Jabones y Productos Especializados (Soaps and Specialized Products) with a Form 483 for multiple violations, including serious quality deficiencies, observed during a March 20-23 inspection.

The inspectors found that the firm lacked CGMP procedures for complaints, OOS investigations, deviation handling, CAPAs, recalls, annual product reviews, training and change control.

The facility didn’t verify that one of its finished drug products conformed to quality standards before shipping the product to the U.S. market. Additionally, the firm accepted a supplier’s certificate of analysis without putting the components through conformity tests.

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