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FDA establishment 1000583780, Charlotte, North Carolina, United States. Part of Sunnex's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 6
Official action indicated: 1
Last inspection ended: Feb 18, 2022
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(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 - production units The design was not validated under defined operating conditions and using initial production units, lots or batches or their equivalents.
21 CFR 820.200(b). Analyzing service report Service reports were not analyzed following appropriate statistical methods.
21 CFR 820.75(b)(2). Documentation of validated process performance There is inadequate documentation of monitoring and control methods and data for a validated process.
21 CFR 820.30(h). Design transfer - Lack of or inadequate procedures Procedures for design transfer have not been adequately established.
21 CFR 820.30(f). Design verification - documentation The design verification results, including identification of the design, method(s), the date and the individual(s) performing the verification, were not documented in the design history file.
21 CFR 820.40(a). Document review, approval by designated individual Documents were not reviewed and not approved by designated individual(s) prior to issuance .
21 CFR 820.200(d). Service reports Service reports do not include the required information.
21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been 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 evaluated and investigated where necessary.
21 CFR 820.184. DHR content The device history record does not demonstrate that the device was manufactured in accordance with 21 CFR 820.
21 CFR 820.75(a). Documentation Process validation activities and results have not been documented and approved.
21 CFR 820.198(c). Investigation of device failures Complaints involving the possible failure of a device, labeling and packaging to meet any of its specifications were not reviewed, evaluated and investigated where necessary.
21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been established.
21 CFR 820.90(b)(2). Product rework documentation, DHR {see also 820.184} Rework and reevaluation activities have not been documented in the device history record.
21 CFR 820.40(a). Document review, approval by designated individual Documents were not approved by designated individual(s) prior to issuance .
21 CFR 820.30(f). Design verification - documentation The design verification results, including, were not documented in the design history file.
21 CFR 820.30(h). Design transfer - Lack of or inadequate procedures Procedures for design transfer have not been established.
21 CFR 820.80(d). Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been adequately established.
21 CFR 820.120(b). DHR documentation of label release {see also 820.184} The DHR does not include records of examination and release of device labeling, including date and signature of the examiner.
21 CFR 820.30(g). Design validation - production units The design was not validated under defined operating conditions and using initial production units, lots or batches or their equivalents.
21 CFR 820.181. DMR - not or inadequately maintained A device master record has not been adequately maintained.
21 CFR 820.200(d). Service reports Service reports are not documented and do not include the required information.
No Action Indicated (NAI)
Jul 12, 2017
Devices · Compliance: Devices
8 cited references
21 CFR 820.184. DHR content The device history record does not demonstrate that the device was manufactured in accordance with the device master record and 21 CFR 820.
21 CFR 820.200(d). Service reports Service reports do not include the required information.
21 CFR 820.181. DMR - not or inadequately maintained A device master record has not been adequately maintained.
21 CFR 820.120(b). Examination for accuracy Labeling was not sufficiently examined by a designated individual for accuracy including before release.
21 CFR 820.40(a). Document review, approval by designated individual Documents were not reviewed and not approved by designated individual(s) prior to issuance .
21 CFR 820.80(d). Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been adequately established.
21 CFR 820.75(b)(2). Documentation of validated process performance There is no and inadequate documentation of monitoring and control methods and data, the date performed, the individual performing the process and the major equipment used for a validated process.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
21 CFR 820.184. Lack of or inadequate DHR procedures Procedures for device history records have not been established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.50(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(a). Personnel Personnel do not have the necessary background, training, and experience to perform their jobs.
21 CFR 820.198(b). Review and evaluation for investigation Not all complaints have been adequately reviewed and evaluated to determine whether an investigation is necessary.
21 CFR 820.184. DHR - not or inadequately maintained A device history record has not been adequately maintained.
21 CFR 820.70(a). Process control procedures, Lack of or inadequate procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
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 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been established.
21 CFR 820.25(b). Training records Personnel training is not documented.
21 CFR 820.90(b)(1). Procedures for product review,disposition lack of/inadequate Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been established.
21 CFR 820.181. DMR - not or inadequately maintained A device master record has not been maintained.
21 CFR 820.50(a). Evaluation of suppliers, contractors, etc., requirements Requirements that must be met by suppliers have not been established.
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. 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 and warning letters
Charlotte, North Carolina, United States. Part of