Vericel Corporation
Form 483 issued July 21, 2023 · Cambridge, Massachusetts
- Inspection
- Jul 13 – Jul 21, 2023
- Investigator
- Nancy L. Neiger
- Observations
- 7
- Pages
- 7
- FEI number
- 3002836339
In short: On July 21, 2023, FDA issued a Form 483 with 7 observations to Vericel Corporation in Cambridge, Massachusetts (FEI 3002836339) after an inspection that ran Jul 13 – Jul 21, 2023. The investigator was Nancy L. Neiger. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce…
- 02
Written procedures are not followed that describe the examinations to be conducted on appropriate samples of…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
This inspection in context
Nancy L. Neiger
3 documents · 2010–2023
Cites 211.42(c)(10)(iv) (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
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 211.42(c)(10)(v)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vericel Corporation?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Vericel Corporation?
Nancy L. Neiger is named on this Form 483, for the inspection of Jul 13 – Jul 21, 2023. Each investigator has a profile showing what they cite most.
When was Vericel Corporation inspected by FDA?
The inspection ran Jul 13 – Jul 21, 2023, and the Form 483 is dated July 21, 2023.
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.