Cascadia Manufacturing, Inc. – FDA Warning Letter, Feb 22, 2008

An FDA inspection of a manufacturing facility in Bellevue, Washington, on multiple dates in January and February 2008, revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering drug products adulterated. Additionally, the firm is marketing unapproved new drugs, violating Sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act.

Key CGMP violations include: 1. Inadequate laboratory testing for active ingredient identity and strength (e.g., CankerMelts). 2. Lack of microbial limits testing for oromucosal drug products. 3. Absence of established acceptance criteria for quality control testing, including microbial limits. 4. Failure to establish written in-process controls for manufacturing processes (e.g., CankerMelts uniformity, heating, pH). 5. No microbiological testing of drug components liable to contamination. 6. Failure to conduct specific identity tests for most drug product components. 7. Improper cleaning and maintenance of equipment (e.g., peeling paint on CankerMelts equipment). 8. Lack of adequate written cleaning procedures, including disinfectant residue removal. 9. Failure to maintain equipment cleaning and sanitization records. 10. No retesting or reexamination of components stored for long periods. 11