Recipient: Digicare Biomedical Technology Inc.
Product:Pulse oximeters and multiparameter patient monitors
Date: 4/26/05

However, your firm lacked major steps for effective internal audits, including design control, software validation, corrective and preventive action (CAPA), and Electrostatic Discharge (ESD) reduction activities. Also, the individual conducting the audits lacks the necessary training and experience to conduct such audits and failed to identify deficient quality matters. Furthermore, audits were conducted by the Quality Assurance Manager, who has direct responsibility over matters being audited. This observation was repeated from the previous inspection and the untitled letter issued in September 2003 (FDA 483, Item #6).

FDA District: Florida District Office