483
American Laboratories, LLCAmerican Laboratories, LLC – FDA 483, Dec 1, 2017
Record Details
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.
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ID · 071f9b7f-43b4-4e78-9205-ea82408b72a3
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