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FDA establishment 1043551, Rural Hall, North Carolina, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 5
Official action indicated: 0
Last inspection ended: Jun 15, 2023
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 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been adequately established to control product that does not conform to specified requirements.
21 CFR 803.18(e). Results of evaluation not in mfr's MDR file The results of the evaluation of each event are not documented and maintained in the manufacturer's MDR event file.
21 CFR 803.17(a)(1). Lack of System for Event Evaluations The written MDR Procedure does not include an internal system which provides for timely and effective identification, communication and evaluation of events that may be subject to medical device reporting requirements.
21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits have not been performed.
21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit 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.
Voluntary Action Indicated (VAI)
Sep 21, 2016
Devices · Compliance: Devices
None posted
No Action Indicated (NAI)
May 8, 2014
Devices · Compliance: Devices
None posted
No Action Indicated (NAI)
Aug 6, 2012
Devices · Compliance: Devices
4 cited references
21 CFR 820.50(b). Supplier notification of changes There is no agreement with suppliers to notify you of changes in the product or service.
21 CFR 820.25(b). Training records Personnel training is not documented.
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 820.60. Identification procedures, Lack of or inadequate procedures Procedures for identifying product during all stages of receipt, production, distribution, and installation have not been established.
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
Rural Hall, North Carolina, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.