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FDA establishment 3014171792, Louisville, Kentucky, United States. Part of Induction Therapies'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: Aug 8, 2025
Warning letters: 2
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 211.188(b). Batch production and Batch Control Record Requirements The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing, processing, packing and holding.
21 CFR 211.182. Written records kept in individual logs Written records of major equipment cleaning, maintenance and use are not included in individual equipment logs.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing.
21 CFR 211.130. Procedures are written, and followed Procedures designed to assure that correct labels, labeling and packaging materials are used for drug products are not written and followed.
21 CFR 211.130(c). Lot or control number assigned The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch.
21 CFR 211.22(a). Contract drug products--lack of responsibility The quality control unit lacks responsibility for approving or rejecting drug products manufactured, processed and packed under contract by another company.
21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in current good manufacturing practices.
21 CFR 211.137(a). Expiration date lacking Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Voluntary Action Indicated (VAI)
Jun 29, 2021
Devices · Compliance: Devices
3 cited references
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 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
21 CFR 820.250(b). Sampling methods - Lack of or inadequate procedures Procedures to ensure sampling methods are adequate for their intended use have not been adequately established.
21 CFR 820.20(e). Quality System Procedures Quality system procedures and instructions have not been established.
21 CFR 820.20(a). Quality policy and objectives The quality policy and quality objectives was/were not established by management with executive responsibility.
21 CFR 820.20(d). Quality plan A quality plan has not been established.
No Action Indicated (NAI)
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
Louisville, Kentucky, United States. Part of