FDA WARNING_LETTER - SANUM-Kehlbeck GmbH & Co. KG - March 26, 2013

This FDA Warning Letter, dated April 11, 2014, addresses SANUM-Kehlbeck GmbH & Co. KG (SANUM) following a March 18-26, 2013 inspection of their Hoya, Germany facilities (Werk I and Werk II). The inspection revealed significant violations of CGMP regulations for finished pharmaceuticals (21 CFR Parts 210 and 211) and deviations from CGMP for active pharmaceutical ingredients (APIs), rendering their products adulterated under 21 U.S.C. 351(a)(2)(B). Additionally, SANUM failed to fulfill registration and listing obligations under Section 510(i)(1), (i)(2), and (j) of the Act, making their drugs misbranded.

Key violations include: - **API CGMP Violation:** Production of highly sensitizing materials like penicillin (Penicillium chrysogenum) was not performed in dedicated areas. Non-penicillin APIs were manufactured on shared equipment used for penicillin production in Werk I, posing contamination risks. The firm's response regarding revalidation and decontamination was deemed inadequate, lacking commitment to full segregation. - **CGMP Drug Product Violations:** Non-penicillin and penicillin-containing finished products were produced in Werk II using shared equipment, creating a serious allergenic hazard. The firm's response was insufficient regarding segregation and decontamination. - **Ase