Vertex Pharmaceuticals Incorporated
Form 483 issued May 4, 2023 · Boston, Massachusetts
- Inspection
- Apr 18 – May 4, 2023
- Investigator
- Robert J. Martin
- Observations
- 1
- Pages
- 3
- FEI number
- 1000513211
In short: On May 4, 2023, FDA issued a Form 483 with 1 observation to Vertex Pharmaceuticals Incorporated in Boston, Massachusetts (FEI 1000513211) after an inspection that ran Apr 18 – May 4, 2023. The investigator was Robert J. Martin. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67(b)(6) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for…
This inspection in context
Robert J. Martin
29 documents · 2014–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmVertex Pharmaceuticals Incorporated history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(b)(6)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vertex Pharmaceuticals Incorporated?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Vertex Pharmaceuticals Incorporated?
Robert J. Martin is named on this Form 483, for the inspection of Apr 18 – May 4, 2023. Each investigator has a profile showing what they cite most.
When was Vertex Pharmaceuticals Incorporated inspected by FDA?
The inspection ran Apr 18 – May 4, 2023, and the Form 483 is dated May 4, 2023.
How do I get the full Form 483 for Vertex Pharmaceuticals Incorporated?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.