FDA WARNING_LETTER - Attix Pharmaceuticals Inc - November 14, 2014

This FDA Warning Letter, dated June 22, 2015, was issued to Attix Pharmaceuticals following an inspection from November 10-14, 2014, at their Toronto, Canada facility. The inspection identified significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs), rendering their APIs adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to prevent cross-contamination of beta-lactam drug products:** Attix Pharmaceuticals failed to use separate facilities, dedicated equipment (e.g., hoods), or air handling systems for manufacturing penicillins, non-penicillin beta-lactams, and non-beta-lactam APIs. Personnel and materials moved freely between areas, increasing cross-contamination risk. The firm's response, detailing HEPA-filtered hoods and cleaning with (b)(4), was deemed insufficient as cleaning cannot substitute for proper segregation, and no scientific justification for using (b)(4) to inactivate beta-lactam rings was provided. The FDA emphasized that no safe level of penicillin contamination exists due to severe allergenic reactions. 2. **Failure to accurately transfer expiry dates:** An internal audit revealed 186 instances where the firm inaccurately transferred manufacturer-assigned expiry/retest dates to customers, extending them by up to (b)(