FDA establishment 3003407523, Allendale, New Jersey, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
FY2018 to FY2027 to date; 0 classified OAI
A hatched bar is a year that is not over, so its count covers only part of the year.
Inspections citing each reference
| Ended | Product and area | Citations | Classification |
|---|---|---|---|
| Sep 29, 2025 | Biologics · Human Cellular, Tissue, and Gene Therapies | 3 cited references
| Voluntary Action Indicated (VAI) |
| Aug 26, 2019 | Biologics · Human Cellular, Tissue, and Gene Therapies | None posted | No Action Indicated (NAI) |
| Apr 26, 2017 | Biologics · Human Cellular, Tissue, and Gene Therapies | None posted | No Action Indicated (NAI) |
| Jun 17, 2014 | Biologics · Human Cellular, Tissue, and Gene Therapies | None posted | No Action Indicated (NAI) |
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters
Allendale, New Jersey, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.