483
United Laboratories Manufacturing, LLCUnited Laboratories Manufacturing, LLC – FDA 483, Aug 26, 2016
Record Details
United 1 International Laboratories, LLC, an OTC drug manufacturer in Carrollton, TX, was inspected by the FDA. The inspection revealed two significant observations related to the firm's quality system and equipment maintenance. Specifically, the firm lacked established procedures for annual product reviews and failed to follow written procedures for cleaning validation of manufacturing equipment.
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ID · 22f9bec9-d67d-4c75-aa63-28883f248043
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