Integra NeuroSciences Ltd. – FDA Warning Letter, Jun 14, 2012

On November 1, 2012, the FDA issued a Warning Letter to Integra NeuroSciences Ltd. following an inspection from June 11-14, 2012, in Hampshire, England. The inspection revealed that the firm's Intracranial Pressure Monitors and Ultrasonic Aspiration devices were adulterated under section 501(h) of the Act, as their manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a))**: The firm's procedure lacked requirements for statistical analysis of quality data, five out of (b)(4) CAPAs reviewed lacked completed/valid effectiveness checks, and no CAPAs were opened for repeated customer complaints related to similar issues (e.g., (b)(4) and (b)(4) ). An original CAPA from February 2010 regarding (b)(4) complaints remained open since March 2011. 2. **Failure to adequately validate processes (21 CFR 820.75(a))**: There was no documentation to demonstrate validation of the manufacturing process for (b)(4) , where full verification including dimensional measurements was not performed. 3. **Failure to establish adequate procedures for quality