FDA 483 - Amsar Private Ltd - July 12, 2012

During an inspection conducted from July 9-10 and July 12, 2012, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Amsar Private Limited, a manufacturing facility located in Indore, India. The inspection identified significant deviations from Current Good Manufacturing Practices (cGMP) intended to ensure product quality and safety. Key observations included widespread issues with facility maintenance and sanitation. Specifically, the FDA noted rusted processing equipment with flaking metal and residue buildup, compromising the integrity of manufacturing processes. Production procedures were found to contribute to potential contamination, such as equipment and lids contacting unsanitary floors, and general unhygienic conditions on production floors, including water and product residue accumulation.Furthermore, the facility exhibited structural deficiencies, including rusted, holed flooring, flaking paint, and openings in the roof and walls, leading to inadequate pest control, evidenced by the presence of a live pigeon. Handwashing facilities were deficient, lacking running water, soap, or towels, and employees engaged in unsanitary handwashing practices. Food-contact surfaces had residue buildup due to poor seam maintenance, and cleaned equipment was improperly stored directly on the ground. Additionally, toilet facilities were unsanitary, and there was no system for sanitizing employee shoes before re-entering production areas.These observations indicate a systemic failure to adhere to fundamental hygiene and facility control standards. Amsar Private Limited is required to respond to the FDA with a comprehensive plan of corrective actions to address each observation and bring the facility into compliance with regulatory requirements.