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FDA establishment 3020929899, Denver, Colorado, United States. Part of Exer Labs's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 1
Last inspection ended: Oct 24, 2024
Warning letters: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 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 820.22. Quality audits - Lack of or inadequate procedures Procedures for quality audits have not been established.
21 CFR 820.20(c). Management review - Lack of or inadequate procedures Procedures for management review have not been established.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed, maintained and implemented.
21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been established.
21 CFR 820.20(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 820.30(a). Design control - no procedures Procedures for design control have not been established.
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 established.
21 CFR 820.170(a). Lack of or inadequate instructions Installation instructions 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.
21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
Official Action Indicated (OAI)
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. 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
Denver, Colorado, United States. Part of