FDA 483 - Sivshree Medittex (India) Pvt. Ltd. - August 06, 2019

Sivshree Medittex (India) Pvt. Ltd., a contract manufacturer in Coimbatore, India, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies including the absence of written Medical Device Reporting procedures, a lack of written agreements with suppliers for change notification, and inadequate procedures for equipment calibration. These findings highlight critical gaps in the firm's quality system.