Haleon US Holdings LLCSeptember 11, 2018

FDA 483 - Haleon US Holdings LLC - September 11, 2018

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GlaxoSmithKline LLC in East Durham, NY, was inspected and received a Form 483 with two observations. The inspection revealed significant deficiencies in manufacturing process validation for toothpaste formulations and a failure to follow established quality control unit procedures. These issues indicate a lack of adequate controls over critical manufacturing and quality systems.

Company: Haleon US Holdings LLC
Inspection Date: September 11, 2018
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East I
Person: Rajiv R. Srivastava (Consumer Safety Officer)

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ID · ce31d7f1-21e2-4865-af4a-9f9fa65672c5