Vericel Corporation
Form 483 issued September 25, 2024 · Cambridge, Massachusetts
- Inspection
- Sep 18 – Sep 25, 2024
- Investigator
- James P. Finn
- Observations
- 2
- Pages
- 5
- FEI number
- 3002836339
In short: On September 25, 2024, FDA issued a Form 483 with 2 observations to Vericel Corporation in Cambridge, Massachusetts (FEI 3002836339) after an inspection that ran Sep 18 – Sep 25, 2024. The investigator was James P. Finn. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 803.50(a)(2) (1×) · 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
Procedures for corrective and preventive action have…
This inspection in context
James P. Finn
10 documents · 2019–2026
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Massachusetts.
The firmVericel Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 803.50(a)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vericel Corporation?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected Vericel Corporation?
James P. Finn is named on this Form 483, for the inspection of Sep 18 – Sep 25, 2024. Each investigator has a profile showing what they cite most.
When was Vericel Corporation inspected by FDA?
The inspection ran Sep 18 – Sep 25, 2024, and the Form 483 is dated September 25, 2024.
How do I get the full Form 483 for Vericel Corporation?
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.