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FDA establishment 1051526, Mcminnville, Tennessee, United States. Part of Vilex in Tennessee's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 4
Official action indicated: 1
Last inspection ended: Jul 19, 2018
Warning letters: 1
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. 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 adequately 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 820.30(g). Design validation- Lack of or inadequate procedures Procedures for design validation have not been adequately established.
21 CFR 820.30(j). Design history file The design history file was not established.
21 CFR 820.30(g). Design validation - Risk analysis Results of the design risk analysis were not adequately documented.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been adequately established.
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(g). Design validation- Lack of or inadequate procedures Procedures for design validation have not been adequately established.
21 CFR 820.30(e). Design review - Lack of or inadequate procedures Procedures for design review have not been adequately established.
21 CFR 820.30(c). Design input - documentation Design input requirements were not adequately documented.
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 adequately established.
21 CFR 820.30(f). Design verification - Lack of or inadequate procedures Procedures for design verification have not been adequately established.
Voluntary Action Indicated (VAI)
Sep 1, 2010
Devices · Compliance: Devices
4 cited references
21 CFR 820.198(d). Evaluation, timeliness, identification Complaints representing events that are MDR reportable were not promptly reviewed, evaluated, and investigated by a designated individual.
21 CFR 820.22. Quality audits - Lack of or inadequate procedures Procedures for quality audits have not been adequately 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 adequately established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
Voluntary Action Indicated (VAI)
Warning Letters
Letters naming this establishment; each opens the letter
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
Mcminnville, Tennessee, United States. Part of