FDA WARNING_LETTER - Scottcare Corporation - January 13, 2012

On February 21, 2012, the FDA issued a Warning Letter to Scottcare Corporation following a January 9-13, 2012 inspection of their Westlake, OH facility, which manufactures telemetry devices. The inspection found the devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. Failure to establish adequate CAPA procedures for analyzing quality data using statistical methodology to identify nonconforming products or quality problems (21 CFR § 820.100(a)(1)). The firm's procedures lacked details on data analysis frequency and statistical methods, failing to identify recurring issues like "bad SD card" complaints. 2. Failure to verify CAPA effectiveness (21 CFR § 820.100(a)(4)), with five of eleven reviewed CAPAs lacking effectiveness checks. 3. Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints (21 CFR § 820.198(a)), as 10 of 11 "non-complaint" records met the definition of a complaint. 4. Failure to adequately investigate complaints involving possible device failures (21 CFR §