483
Vertex Pharmaceuticals IncorporatedVertex Pharmaceuticals Incorporated – FDA 483, May 4, 2023
Record Details
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.
- Person
View Company Profile
ID · 5261a188-7e21-4926-88da-807f338c3960
Other documents for Vertex Pharmaceuticals Incorporated
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.