Microbiology FDA 483 (Eugia Pharma Specialities): There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed
Investigation APL-AN-PNC-22-0125 was opened when one turbid vial in ***#64, produced during the aseptic process simulation for the *** Line,