ULTRAtab Laboratories, Inc.February 1, 2019

FDA 483 - ULTRAtab Laboratories, Inc. - February 01, 2019

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Record Details

An FDA inspection of Vitratab Laboratories, Inc. in Highland, NY, from January 25 to February 1, 2019, revealed a significant quality control issue. The firm's master manufacturing record for dietary supplements failed to identify necessary specifications, specifically microbial limits, to ensure product quality. This indicates a deficiency in their manufacturing process controls.

Company: ULTRAtab Laboratories, Inc.
Inspection Date: February 1, 2019
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East I
Person: Marie-Elena C Puleo

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ID · 44a605d4-aa61-4044-a075-a2ce67bd620c