United Laboratories Manufacturing, LLCAugust 26, 2016

FDA 483 - United Laboratories Manufacturing, LLC - August 26, 2016

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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.

Company: United Laboratories Manufacturing, LLC
Inspection Date: August 26, 2016
Product Type: Drugs
Office: Dallas District Office
Person: Patrice S. Hall ( Investigator )

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ID · 22f9bec9-d67d-4c75-aa63-28883f248043