horiba instruments, inc – FDA Warning Letter, Mar 1, 2012

On July 25, 2012, the FDA issued a Warning Letter to Horiba Instruments, Inc., dba Horiba Medical, following an inspection from February 15 to March 1, 2012. The inspection revealed that the ABX Micros 60 IM2 Hematology Analyzer is adulterated because the firm lacks an approved premarket approval (PMA) or investigational device exemption. It is also misbranded for failure to submit a 510(k) premarket notification and for failing to report corrections and removals, specifically regarding Minotrol 16 Creatinine devices, as required by 21 CFR Part 806.

The firm's devices are also adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Significant QS violations include: 1. Failure to establish and maintain design control procedures for the ABX Micros 60 IM2 (21 CFR 820.30(a)). 2. Inadequate procedures for validating device design, specifically for the ABX Micros 60 IM2 (21 CFR 820.30(g)). 3. Failure to adequately implement CAPA procedures, including outdated databases and lack of required meetings (21 CFR 820.