FDA 483 - Ampak Chemicals Incorporated - April 09, 2021

Ampak Chemicals Incorporated, an OTC drug manufacturer in Carson, CA, was inspected and found to have severe deficiencies across its manufacturing operations for bulk hand sanitizer. The firm lacks a functional quality control unit, written procedures for material control, production, process controls, and laboratory testing, and fails to maintain its facility and calibrate critical equipment. These issues indicate a fundamental absence of Good Manufacturing Practices.