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FDA establishment 3003382542, Charlotte, 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: Feb 17, 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 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
21 CFR 820.50(a)(1). Evaluation and Selection, Suppliers, Contractors, etc. Potential suppliers, contractors and consultants were not evaluated and selected based on their ability to meet specified requirements.
21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been documented.
21 CFR 820.50. Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established.
21 CFR 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review 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 820.170(a). Lack of or inadequate instructions Installation instructions, inspection instructions and test procedures have not been established.
21 CFR 820.50(a)(1). Documented evaluation The evaluation of potential suppliers, contractors and consultants was not documented.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed and implemented.
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
Charlotte, North Carolina, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.