Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
FDA establishment 3011528328, West Columbia, South Carolina, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 0
Last inspection ended: Jul 18, 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(g). Design validation - simulated testing The design was not validated under actual or simulated use conditions.
21 CFR 820.120(d). Records, DHR {see also 820.184(e)} Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the DHR.
21 CFR 820.72(a). Equipment control activity documentation Equipment calibrations have not been documented.
21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been adequately established.
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 investigated where necessary.
21 CFR 820.120(b). Examination for accuracy Labeling was not sufficiently examined by a designated individual for accuracy including control numbers before release.
21 CFR 820.181. DMR - not or inadequately maintained A device master record has not been maintained.
Voluntary Action Indicated (VAI)
Jul 17, 2018
Devices · Compliance: Devices
2 cited references
21 CFR 820.72(a). Equipment suitability & capability Certain inspection, measuring and test equipment is not suitable for its intended purposes and capable of producing valid results.
21 CFR 820.72(a). Equipment control activity documentation Equipment calibrations, inspections, checks and maintenance activities have not been documented.
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
West Columbia, South Carolina, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.