Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
FDA establishment 3015404862, Durham, North Carolina, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 0
Last inspection ended: Jan 26, 2024
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
Biologics · Human Cellular, Tissue, and Gene Therapies
2 cited references
21 CFR 600.14(c). When to report Biological product deviations are not reported within the 45 calendar day timeframe.
21 CFR 211.192. Extent of discrepancy, failure investigations Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy.
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