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

Source: https://www.globalkeysolutions.net/records/warning_letter/racer-technology-pte-ltd/5a05222a-d8ba-4674-8882-efac1437a5b3

> FDA WARNING_LETTER for Racer Technology Pte Ltd on June 06, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Racer Technology Pte Ltd
- Inspection Date: 2013-06-06
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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,

## Related Officers

- [President](https://www.globalkeysolutions.net/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

Company: https://www.globalkeysolutions.net/companies/racer-technology-pte-ltd/42ceb5ff-81b5-4472-9c5c-5cb6f5215f15

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7