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FDA establishment 3016555297, Greensboro, North Carolina, United States. Part of Horizon Tool Inc.'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: Jan 16, 2025
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 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
21 CFR 211.110(c). In-process materials characteristics testing In-process materials are not tested for identity, strength, quality and purity and approved or rejected by the quality control unit during the production process and after storage for long periods.
21 CFR 211.113(a). Procedures for non-sterile drug products Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not written and followed.
21 CFR 211.134(a). Correct labels during finishing operations Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the correct label.
21 CFR 211.192. No written record of investigation Written records are not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.
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. 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
Greensboro, North Carolina, United States. Part of