FDA WARNING_LETTER - Ebewe Pharma Ges MBH Nfg KG - October 23, 2012

The FDA issued a Warning Letter to Ebewe Pharma Ges. m.b.H Nfg. KG following an October 15-23, 2012, inspection of their Austrian pharmaceutical manufacturing facility. The inspection revealed significant violations of CGMP regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated. Additionally, two specific drug products, (b)(4) Injection (b)(4) mg/mL and (b)(4) Injection (b)(4) mg/mL, were distributed without required FDA marketing applications, making them unapproved new drugs.

Key violations include: 1. **Failure to obtain FDA approval for quality control changes:** The firm manufactured and distributed (b)(4) lots of finished parenteral drugs to the U.S. using unapproved visual inspection procedures, despite being repeatedly informed by FDA not to distribute these products until supplements were approved. FDA had also informed the firm on March 14, 2012, that these supplements were not approvable. The firm ceased using the unapproved method but failed to provide a plan for products already distributed. 2. **Inadequate test procedures for finished drug product conformance:** The visual inspection procedures for critical defects like particulate matter in parenteral drug vials were inadequate, as operators repeatedly failed to detect visible particles (e.g., (b)(4), (b)(4), and unknown residues) on at least