FDA Inspection
Vertex Pharmaceuticals IncorporatedVertex Pharmaceuticals Incorporated – FDA Inspection, Oct 16, 2014
Record Details
This FDA Inspection record concerns Vertex Pharmaceuticals Incorporated, with an inspection on October 16, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 16, 2014
- Product Type
- Drugs
View Company Profile
ID · 97e56b9d-5cb4-4782-83df-22c75a2e5dba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 902520
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 314.80(b)Failure to develop written procedures
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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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