FDA Inspection
Vertex Pharmaceuticals IncorporatedVertex Pharmaceuticals Incorporated – FDA Inspection, Sep 7, 2017
Record Details
This FDA Inspection record concerns Vertex Pharmaceuticals Incorporated, with an inspection on September 7, 2017, issued by the New England District Office, covering human drugs.
- People
- Christina A. Capacci-Daniel (Issuing Officer)
- Sean R. Marcsisin (FDA Associated Person)
- Sharmista Chatterjee (Issuing Officer)
- Yong Hu (Issuing Officer)
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ID · b28bfc95-4c50-4ca9-99d0-5d6d7d7b88e2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1024312
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(a)Deviations from laboratory control requirements
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Other FDA inspections of Vertex Pharmaceuticals Incorporated
14| Date | Classification | Office | Project area |
|---|---|---|---|
| July 31, 2026 | Not classified | New England District Office | |
| March 3, 2026 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 1, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 4, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 19, 2022 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Vertex Pharmaceuticals Incorporated
- FDA Inspection 1333028 - 2026-07-31
- FDA Inspection 1306258 - 2026-03-03
- FDA Inspection 1246447 - 2024-08-01
- FDA Inspection 1205834 - 2023-05-04
- FDA Inspection 1180001 - 2022-08-19
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