FDA WARNING_LETTER - Optilasa SA - June 02, 2010

On May 31-June 2, 2010, an FDA inspection of Optilasa SA in Madrid, Spain, revealed that their manufactured tonometers are adulterated under 21 U.S.C. 351(h) because their manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to the Quality System (QS) regulation (21 CFR Part 820). The firm's June 24, 2010, response to the FDA 483 was not reviewed due to late submission.

Violations include: 1. Failure to establish and maintain adequate procedures for design changes (21 CFR 820.30(i)), with no design change procedure for tonometers. 2. Failure to establish and maintain a device history file (DHF) for each device type (21 CFR 820.30(j)), specifically for Applanation Tonometer Models OP1H and OPIS. 3. Failure to develop, conduct, control, and monitor production processes to ensure device conformity to specifications, including inconsistent workmanship criteria in Work Instruction IT-20-01 (21 CFR 820.70(a)(5)). 4. Failure to establish and maintain adequate procedures for incoming product acceptance, inspection, testing, or verification, and documentation of acceptance/rejection (