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FDA establishment 3016872494, Statesville, North Carolina, United States. Part of Spintech's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 0
Last inspection ended: Jun 8, 2022
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 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review have not been established.
21 CFR 820.184. DHR - not or inadequately maintained A device history record has not been adequately maintained.
21 CFR 820.120(b). DHR documentation of label release {see also 820.184} The DHR does not include records of examination and release of device labeling, including date and signature of the examiner.
21 CFR 820.50(b). Supplier notification of changes There is no agreement with suppliers and contractors to notify you of changes in the product or service.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
21 CFR 820.22. Quality audits - Lack of or inadequate procedures Procedures for quality audits have not been established.
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 validated according to established procedures.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed and implemented.
21 CFR 820.160(b). Distribution records Distribution records do not include or refer to the location of required information.
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
Statesville, North Carolina, United States. Part of