# FDA WARNING_LETTER - Superex Canada Ltd - January 22, 2013

Source: https://www.globalkeysolutions.net/records/warning_letter/superex-canada-ltd/737b4e04-d52e-4fb4-8ea3-4ddf92fb6897

> FDA WARNING_LETTER for Superex Canada Ltd on January 22, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Superex Canada Ltd
- Inspection Date: 2013-01-22
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On January 21-22, 2013, an FDA inspection of Superex Canada Ltd. in Toronto, Canada, revealed that their first aid and emergency response kits, classified as medical devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's February 12, 2013, response to the FDA 483 was deemed inadequate.

Key violations include:
1.  **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: No written CAPA procedure, and the complaint handling procedure lacked specifics. The firm's response to add CAPAs to the complaint procedure was insufficient without documentation of implementation or a retrospective review.
2.  **Failure to control nonconforming product (21 CFR 820.90(a))**: The quarantine area for expired/recalled items lacked physical separation or signage. The firm's response of establishing a signed quarantine area was inadequate without evidence of systemic corrective action.
3.  **Failure to establish purchasing control procedures (21 CFR 820.50)**: No written procedures for qualifying and auditing suppliers. The firm's response lacked documentation of correction or corrective action.
4.  **

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/superex-canada-ltd/f96ff14f-748c-4155-8350-8d246241ab41

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