Oncotec Pharma Produktion GmbH – FDA EIR, Sep 27, 2019

The U.S. Food and Drug Administration (FDA) conducted a Good Manufacturing Practice (GMP) surveillance inspection of Oncotec Pharma Produktion GmbH, a foreign sterile contract drug manufacturer located in Dessau Rosslau, Germany. The inspection took place from September 19 to September 27, 2019, under the regulatory framework for Sterile Drug Product Inspections (CPGM 7356.002A).

During the inspection, the FDA identified three main observations. Firstly, a cracked and damaged stopper bowl, found in an ISO 5 cleanroom and repaired with non-pharmaceutical grade glue, lacked a preventative maintenance program. Secondly, the firm's Standard Operating Procedure (SOP) for visual inspection did not specify the number of attempts permitted for operators to pass their requalification exam. Lastly, the company lacked a written procedure for conducting smoke studies, which are crucial for assessing airflow patterns in controlled environments.

Management was also advised about the absence of a replacement schedule for non-critical parts on a production line. Oncotec Pharma Produktion GmbH committed to submitting a written response to the FDA within 15 business days. The inspection was classified as Voluntary Action Indicated (VAI), signifying that corrective actions are necessary but do not warrant immediate administrative or regulatory action.