Criticare Systems (Malaysia) Sdn. Bhd. – FDA Warning Letter, Sep 19, 2014

On January 15, 2015, the FDA issued a Warning Letter to Criticare Systems (Malaysia) Sdn. Bhd. following an inspection from September 15-19, 2014. The inspection revealed that the firm's automated external defibrillators (AEDs) are adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act, as their manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: The firm did not audit the effectiveness of vendor corrective actions as required by its own procedure. 2. **Failure to maintain complaint files and procedures (21 CFR 820.198(a))**: Complaint handling procedures lacked requirements for investigating device failures and maintaining investigation records. 3. **Failure to maintain investigation records (21 CFR 820.198(e))**: The firm did not investigate or document reasons for not investigating customer feedback, nor did it document investigation results for several complaints. 4. **Failure to establish and maintain procedures for changes (21 CFR 820.70(b))**: Process change procedures lacked requirements for verification/validation of changes,