FDA WARNING_LETTER - Moor Instruments Ltd - August 21, 2014

On December 18, 2014, the FDA issued a Warning Letter to Moor Instruments Ltd. following an inspection from August 18-21, 2014, at their facility in Axminster, UK. The inspection revealed that their moorVMS-LDF and moorVMS-LDF-HP Laser Doppler Blood Flow Monitor devices are adulterated under section 501(h) of the Act, due to non-conformity with the Quality System (QS) regulation (21 CFR Part 820).

The FDA identified six significant violations: 1. Failure to establish and maintain adequate procedures for validating device design (21 CFR 820.30(g)), specifically regarding undocumented raw data and test results for moorVMS-LDF. 2. Failure to establish and maintain adequate procedures for identification, documentation, validation/verification, review, and approval of design changes before implementation (21 CFR 820.30(i)). This included a lack of validation/verification requirements in procedures and for specific design changes (e.g., 1049, 1075, 798). 3. Failure to establish and maintain rework procedures, including retesting and reevaluation of nonconforming product (21 CFR 820.90(b)(2)). Eight nonconformance records lacked documented retesting/