Lonza Biologics, Inc. – FDA Warning Letter, May 6, 2011

On September 1, 2011, the FDA issued a Warning Letter to Lonza Biologics, Inc. following an inspection from April 4 to May 6, 2011, at their Hopkinton, MA facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211) and Active Pharmaceutical Ingredients (APIs), rendering their drug products and APIs adulterated.

Key violations include: - **Inadequate investigations for drug products:** Failure to thoroughly investigate an unidentified peak co-eluting with the primary product peak in ONTAK stability analyses, lacking sufficient scientific rationale for the observation and its impact. - **Inadequate investigations for APIs:** Failure to investigate ONTAK Drug Substance Lots that did not meet release specifications for residual (b)(4), and failure to identify a root cause for Out-of-Specification (OOS) results. - **Unvalidated analytical test methods for APIs:** Failure to validate the ONTAK (b)(4) method for potency and robustness, specifically regarding column variability and inadequate separation. - **Quality Unit deficiencies:** - Failure to ensure ONTAK API lots met revised specifications for (b)(4) levels, releasing a lot with an outdated concentration. - Failure to reanalyze ONTAK production lots using a validated DNA (b)(4) method, instead using a general, un