Vericel Corporation
FDA inspection history in Cambridge, Massachusetts, 2023 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–24Two Form 483s, at Cambridge, Massachusetts.
- 2023The longest 483 on file: 7 observations over 7 pages at Cambridge, Massachusetts.
Cited most
Across all Vericel observations on file
- 21 CFR 211.42(c)(10)(iv)Design and construction features2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.165(d)Testing and release for distribution1
- 21 CFR 211.192Production record review1
The complete Vericel file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Cambridge, Massachusetts
Two Form 483s · 2023 to 2024 · 9 observations
Latest: Form 483, Sep 25, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-09-25 | 483 Form 483 | Cambridge, Massachusetts | 2 | $99 |
| 2023-07-21 | 483 Form 483 | Cambridge, Massachusetts | 7 | $99 |
Investigators on these documents
FEI number 3002836339 · most recent document Sep 25, 2024
About Vericel Corporation
How many FDA Form 483s has Vericel Corporation received?
FDA Intel has 2 Form 483s on file for Vericel Corporation; the most recent is dated Sep 25, 2024.
When was Vericel Corporation last inspected by FDA?
The most recent FDA inspection document on file for Vericel Corporation is a Form 483 dated Sep 25, 2024, for the site in Cambridge, Massachusetts.
What did FDA cite at Vericel Corporation?
The regulations cited most in the observations on file for Vericel Corporation are 21 CFR 211.42(c)(10)(iv) (Design and construction features), 2 times; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time.