FDA 483 - Eurofins SF Analytical Laboratories, Inc. - August 09, 2022

Eurofins SF Analytical Laboratories, Inc. in Horsham, PA, a contract laboratory, received a Form 483 for deficiencies in laboratory record-keeping and investigation processes. The firm failed to maintain complete documentation of microbial growth recovered from raw materials and finished products. Additionally, investigations into unexplained discrepancies and non-conformances were found to be inadequate, lacking supported conclusions and effective corrective actions.