FDA WARNING_LETTER - Tyco Healthcare Canada - October 15, 2010

On February 14, 2011, the FDA issued a Warning Letter to Tyco Healthcare Canada following an inspection from October 12-15, 2010, at their Pointe-Claire, Canada facility. The inspection revealed that the firm's saline and heparin vascular access flush syringes, classified as devices, were adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act. This was due to non-conformity with the current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation, 21 CFR Part 820. The firm's response to the FDA 483 was not reviewed as it was not received within 15 business days.

Violations included: 1. **Failure to adequately validate processes (21 CFR 820.75(a)):** The Installation/Operational Qualification Protocol for the (b)(4) System ID 33804B did not document that equipment met installation requirements, plunger defect rates met specifications, false positive rates met specifications for 5/12 mL syringes, or that the new system's detection rates for (b)(4) micron particles performed better than the previous system or met USP requirements. 2. **Failure to establish and maintain adequate corrective and preventive action procedures (21 CFR 820.100(a)(5)):