FDA WARNING_LETTER - Alere San Diego, Inc. - June 27, 2012

An FDA inspection of Alere San Diego, Inc. from March 12 to June 27, 2012, revealed that the firm's Triage brand cardiac marker and TOX Drug Screen devices are adulterated, as their manufacturing methods, facilities, or controls do not conform to the Quality System regulation (21 CFR Part 820). The firm's July 17, 2012, response to the FDA 483 observations was largely deemed inadequate.

Key violations include failures in process validation (21 CFR 820.75(a)), design output documentation (21 CFR 820.30(a)), control and disposition of nonconforming product (21 CFR 820.90(a), 820.90(b)), environmental controls (21 CFR 820.70(c)), use of statistical techniques (21 CFR 820.250(a)), document control (21 CFR 820.40), and maintenance of device history records (21 CFR 820.184). Specific issues ranged from inadequate oven specifications and assembly process validation to misaligned release specifications, improper handling of out-of-specification products, insufficient ESD controls, flawed stability testing, and the use of unapproved draft procedures.

The FDA requires prompt corrective actions, including systemic changes, with a written response within fifteen business days detailing steps taken, prevention plans, and a timetable for completion. Failure to comply may lead to regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts, premarket approvals, and Certificates to Foreign Governments. The letter emphasizes that these violations may indicate broader issues in the firm's quality management systems.