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FDA establishment 1526854, Maumee, Ohio, United States. Part of Bionix'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: Jul 14, 2026
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.
ISO 13485:2016 Clause 7.4.3. Purchased product verification activities not established or implemented The inspection or other activities necessary for ensuring that purchased product meets specified purchasing requirements were not adequately established and implemented.
ISO 13485:2016 Clause 7.1. Records of risk management activities in product realization not maintained Records of risk management activities in product realization were not adequately maintained.
21 CFR 820.198(d). Records of MDR Investigation Investigation records of MDR reportable complaints do not include required information.
ISO 13485:2016 Clause 7.4.1. Supplier evaluation and selection criteria do not include required elements Criteria for the evaluation and selection of suppliers were not based on the supplier's ability to provide product that meets requirements, based on the performance of the supplier, based on the effect of the purchased product on the quality of the device and proportionate to the risk associated with the medical device.
21 CFR 820.198(e). Records of complaint investigation - UDI Records of complaint investigations do not include required information, including any unique device identifier (UDI) or universal product code (UPC).
ISO 13485:2016 Clause 7.3.6. Design and development verification not performed Design and development verification was not adequately performed in accordance with planned and documented arrangements to ensure that design and development outputs met design and development input requirements.
ISO 13485:2016 Clause 4.1.2. Risk-based approach not applied to QMS processes A risk-based approach to the control of the appropriate processes needed for the quality management system has not been adequately applied.
ISO 13485:2016 Clause 8.4. Procedures for analysis of data not documented Procedures were not adequately documented to determine, collect, and analyze appropriate data to demonstrate the suitability, adequacy, and effectiveness of the quality management system.
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.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
21 CFR 820.181. DMR - not or inadequately maintained A device master record has not been maintained.
21 CFR 820.25(b). Training records Personnel training is not documented.
21 CFR 820.50(a)(3). Acceptable supplier records, inadequate records Records of acceptable consultants 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 adequately established.
21 CFR 803.17(a)(1). Lack of System for Event Evaluations The written MDR Procedure does not include an internal system which provides for the timely and effective communication and evaluation of events that may be subject to medical device reporting requirements.
21 CFR 820.30(a). Design control - no procedures Procedures for design control have not been established.
21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been 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 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
21 CFR 803.17(a)(2). Lack of System for Determining MDR Events The written MDR procedure does not include an internal system which provides for a standardized review process/procedure for determining when an event meets the criteria for reporting.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
21 CFR 820.50(a)(1). Evaluation and Selection, Suppliers, Contractors, etc. Potential suppliers and contractors were not evaluated and selected based on their ability to meet specified requirements.
21 CFR 820.50(b). Approval, inadequate purchasing data Purchasing data that clearly describe or reference specified requirements for purchased or otherwise received product and services have not been established.
21 CFR 820.198(c). Investigation of device failures Complaints involving the possible failure of to meet any of its specifications were not investigated where necessary.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been established.
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
Maumee, Ohio, United States. Part of