FDA 483 - Glicerinas Industriales, S.A de C.V - May 12, 2023

Glicerinas Industriales, S.A de C.V, a repackager/relabeler in Zapopan, Jalisco, Mexico, was cited during an FDA inspection for failing to thoroughly investigate unexplained discrepancies. Specifically, the firm did not investigate numerous batches of product found to contain various particles like insects, hair, and fabric. This indicates a significant quality control issue regarding product purity and batch record review.