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FDA establishment 3030977779, Charleston, South 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: Mar 14, 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 820.50(a)(3). Acceptable supplier records, inadequate records Records of acceptable suppliers and contractors have not been established.
21 CFR 820.30(b). Design plans - Lack of or inadequate Design plans that describe or reference the design and development activities and define responsibility for implementation have not been established.
21 CFR 820.30(g). Design validation - documentation The results of design validation, including identification of the design, method(s), the date and the individual(s) performing validation, were not documented in the design history file.
21 CFR 820.80(d). Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been established.
21 CFR 820.30(d). Design output - documentation Design output was not documented before release.
21 CFR 820.180. Availability Required records are not maintained at a location that is reasonably accessible to responsible officials of the manufacturer and to employees of the FDA.
21 CFR 820.184. DHR - not or inadequately maintained A device history record has not been maintained.
21 CFR 820.50(a)(1). Documented evaluation The evaluation of potential suppliers and contractors was not documented.
21 CFR 820.120(b). Labeling inspection - UDI Labeling was not sufficiently examined by a designated individual for accuracy including unique device identifier (UDI) or universal product code (UPC).
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
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.
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
Charleston, South Carolina, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.