Glaxo Operations UK LimitedSeptember 6, 2019

FDA 483 - Glaxo Operations UK Limited - September 06, 2019

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Record Details

During an inspection of Glaxo Operations UK Limited in Ware, Hertfordshire, the FDA observed a lack of established procedures to prevent objectionable microorganisms in non-sterile drug products. Specifically, there was no sanitization of critical water supply loops feeding manufacturing and active pharmaceutical ingredient suites. This indicates a significant concern regarding microbial control within the facility's production environment.

Company: Glaxo Operations UK Limited
Inspection Date: September 6, 2019
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Erika V. Butler (Compliance Officer / Investigator)

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