# FDA 483 - Vertex Pharmaceuticals Incorporated - May 04, 2023

Source: https://www.keypedia.com/records/483/vertex-pharmaceuticals-incorporated/5261a188-7e21-4926-88da-807f338c3960

> FDA 483 for Vertex Pharmaceuticals Incorporated on May 04, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vertex Pharmaceuticals Incorporated
- Inspection Date: 2023-05-04
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: 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.

## Related Officers

- [Robert J. Martin](https://www.keypedia.com/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)

Company: https://www.keypedia.com/companies/vertex-pharmaceuticals-incorporated/f2bc62b8-1ece-42d2-b058-39466a256c74

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94