483
Haleon US Holdings LLCHaleon US Holdings LLC – FDA 483, Sep 11, 2018
Record Details
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.
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ID · ce31d7f1-21e2-4865-af4a-9f9fa65672c5
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