FDA WARNING_LETTER - Activa Brand Products, Inc. - May 27, 2010

An FDA inspection of Activa Brand Products, Inc. in Cornwall, Canada, from May 25-27, 2010, revealed that their AdvantaJet, AdvantaJet ES, and GentleJet Needle-Free Injectors are adulterated under section 501(h) of the Act. The firm's manufacturing, packing, storage, or installation methods and controls were not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation, 21 CFR Part 820. Key violations included: 1) Failure to establish and maintain adequate procedures for process validation (21 CFR 820.75(a)), specifically regarding packaging validation, with the firm's response deemed inadequate. 2) Failure to establish and maintain adequate procedures for corrective and preventive action (21 CFR 820.100(a)), as evidenced by undocumented investigations and actions for defective coiled springs, with the response also inadequate due to ongoing investigation. 3) Failure to ensure finished devices meet acceptance criteria prior to release (21 CFR 820.80(d)), as a device was released despite failing calibration, and the firm's response was inadequate. Due to these serious violations, the devices remain subject to refusal of admission under an import alert. The firm must provide a written response within fifteen working days detailing corrective actions, prevention plans, and timelines, including completed validation reports and investigation conclusions, to address these significant quality system and compliance issues.