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FDA establishment 1000112932, Smyrna, Tennessee, United States. Part of Better Water's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 6
Official action indicated: 0
Last inspection ended: Jun 26, 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 820.120(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 820.70(i). Software validation for automated processes Software used as part of the quality system has not been validated for its intended use according to an established protocol.
21 CFR 820.22. Quality Audit/Reaudit - documentation The dates of quality audits have not been documented.
21 CFR 820.40(b). Change records, content Records of changes did not include the approval date.
Voluntary Action Indicated (VAI)
Jul 16, 2010
Devices · Compliance: Devices
3 cited references
21 CFR 820.20(b)(3). Management representative No management representative had been appointed to ensure that quality system requirements are met, and to report to management on the performance of the quality system.
21 CFR 820.25(b). Training records Employee training is not fully documented.
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 complete.
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
Smyrna, Tennessee, United States. Part of