FDA Inspection at Bioberica Nets 5-item 483

An FDA January inspection at Bioiberica (Barcelona, Spain) resulted in a five-item FDA-483 that cited significant GMP violations at the drug substance manufacturing facility. For example, the 483 said the firm’s cleaning procedures for manufacturing equipment were not validated to facilitate adequate cleaning and contamination prevention measures. It also found that control procedures were not established to monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of the drug substance.

Additionally, the inspection took issue with the firm’s quality control unit after the agency reviewed electronic HPLC data for assay testing, specifically citing the firm’s detection of undesirable results and retesting until desirable results were achieved. The original test results were not reported, FDA said, and no laboratory investigation was initiated as required by its out-of-specification procedures.