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FDA establishment 3010785603, Fiskeville, Rhode Island, 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: Dec 22, 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(f). Design verification - Lack of or inadequate procedures Procedures for design verification have not been adequately established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.184. DHR - not or inadequately maintained A device history record has not been adequately maintained.
21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
21 CFR 820.150. Lack of or inadequate procedures for storage. Procedures for the control of storage areas and stock rooms have not been adequately established.
21 CFR 820.30(c). Design input - Lack of or inadequate procedures Procedures for design input have not been adequately established.
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
Fiskeville, Rhode Island, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.