FDA 483 - American Laboratories, LLC - December 01, 2017

An FDA inspection of American Laboratories Inc. in Omaha, NE, from November 27 to December 1, 2017, revealed two significant observations. The firm's cleaning procedures for rooms and equipment used in Active Pharmaceutical Ingredient processing were found to be incomplete. Additionally, the Microbiology Laboratory failed to consistently record all necessary data, such as weights, volumes, reagents, and media, during stability testing.