FDA WARNING_LETTER - Racer Technology Pte Ltd - June 06, 2013

On June 3-6, 2013, the FDA inspected Racer Technology Pte. Ltd. in Singapore, finding its cochlear implant accessories (earhooks, battery chargers) adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's June 19, 2013, response to the FDA 483 was deemed inadequate for multiple violations.

Key violations include: 1. **Failure to establish and maintain procedures for changes (21 CFR 820.70(b))**: The firm lacked qualification records for a new (b)(4) and documentation for its implementation. The response did not address verification/validation and documentation deficiencies. 2. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: The procedure RACER-QP16 lacked requirements for analyzing quality data, using statistical methodology, and verifying/validating CAPAs. The updated procedure still omitted statistical methodology and verification/validation requirements. 3. **Failure to document CAPA activities (21 CFR 820.100(b))**: RACER-QP16 did not ensure documentation of all CAPA activities (analysis, investigation, actions, verification/validation, change control,