483
Vertex Pharmaceuticals IncorporatedFDA 483 - Vertex Pharmaceuticals Incorporated - May 04, 2023
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An FDA inspection of Vertex Pharmaceuticals Incorporated in Boston, MA, revealed deficiencies in equipment cleaning and maintenance procedures. The firm failed to adequately qualify cleaning processes for equipment used in manufacturing Fixed Dose Combination Tablets, specifically by not evaluating bioburden levels. Additionally, the effectiveness of disinfection on all product contact surfaces was not fully demonstrated.
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