FDA 483 - Hameln RDS S.R.O. - August 05, 2022

An FDA inspection of Hameln RDS A.S., an API manufacturer in Modra, Slovakia, identified significant deficiencies within its quality control unit. The firm failed to adequately follow written procedures for deviation control, including timely notification and proper root cause identification. Additionally, critical process parameters were not properly evaluated, documented, or monitored during manufacturing operations.