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FDA establishment 3009657922, Wilmington, North Carolina, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 3
Official action indicated: 0
Last inspection ended: Dec 11, 2025
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.
21 CFR 820.30(j). Design history file The design history file does not demonstrate that the design was developed following the approved design plan.
21 CFR 820.75(a). Documentation Process validation activities and results have not been adequately documented and adequately approved.
21 CFR 820.50(a)(2). Supplier oversight The type and extent of control to be exercised over suppliers was not clearly defined.
21 CFR 820.80(d). Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been established.
21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been documented.
21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is inadequate.
21 CFR 820.22. Quality Audits - defined intervals Quality audits were not performed at defined intervals and at sufficient frequency to determine whether the quality system activities and results comply with quality system procedures.
7382.850, Inspection of Medical Device Manufacturers
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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports
Wilmington, North Carolina, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.