FDA 483 - AndersonBrecon Inc. - February 25, 2022

AndersonBrecon Inc. dba PCI Pharma Services in Rockford, IL, a drug packaging and labeling facility, was cited for failing to follow written production and process control procedures. The inspection revealed deficiencies in batch record review, where a required temperature report was missing, and in deviation investigations, which were not closed within the established 30-day timeframe. These issues indicate a lack of adherence to established quality control processes.