Superex Canada Ltd – FDA Warning Letter, Jan 22, 2013

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. **