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FDA establishment 3003462036, Fountain Inn, South Carolina, United States. Part of Erchonia's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 7
Official action indicated: 3
Last inspection ended: Dec 14, 2018
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 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 812.46(a). Sponsor securing investigator compliance An investigator was not complying with the signed agreement, investigational plan and requirements of the regulations and.
21 CFR 812.43(c)(5). No financial disclosure info in investigator agreement A signed agreement was not obtained from each participating investigator that includes sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement.
21 CFR 812.40. Sponsors' general responsibilities For an investigational study, proper monitoring was not ensured and IRB review and approval were not ensured.
Official Action Indicated (OAI)
May 16, 2018
Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices; Devices · Radiation Control and Health Safety Act
3 cited references
21 CFR 820.80(c). Documentation In-process inspections, tests, or other verification activities and approvals were not documented.
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. Lack of or inadequate DHR procedures Procedures for device history records have not been established.
Voluntary Action Indicated (VAI)
Mar 12, 2015
Devices · Bioresearch Monitoring
None posted
Voluntary Action Indicated (VAI)
Sep 5, 2012
Devices · Radiation Control and Health Safety Act
None posted
Voluntary Action Indicated (VAI)
Jul 29, 2011
Devices · Compliance: Devices
2 cited references
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been established.
21 CFR 820.75(a). Documentation Process validation activities and results have not been documented and approved.
21 CFR 820.25(b). Training records Employee training is not fully documented.
21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is incomplete.
21 CFR 820.70(i). Software validation for automated processes Software used as part of production has not been validated for its intended use according to an established protocol.
21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance or rejection of incoming product were not defined, documented, complete, and implemented.
21 CFR 820.198(c). Investigation of device failures Complaints involving the possible failure of a device to meet any of its specifications were not evaluated and investigated where necessary.
21 CFR 820.100(a)(1). Procedure for analysis of data sources The corrective and preventive procedures addressing the analysis of sources of quality data to identify existing and potential causes of nonconforming product or other quality problems were not documented.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures were not completed and followed for the validation or verification of design changes before their implementation.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures were not complete and followed for the control of products that do not conform to specifications.
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
Fountain Inn, South Carolina, United States. Part of