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FDA establishment 3001236991, Wixom, Michigan, United States. Part of Rockwell Medical, Inc.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 7
Official action indicated: 1
Last inspection ended: Nov 20, 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 806.20(b)(4). Justification for not reporting A justification for not reporting the correction or removal action to FDA that included conclusions by a designated person was not included in the record.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.72(b). Remedial action When test/measurement equipment was found to not meet accuracy and precision limits, inadequate action was taken to evaluate whether there was any adverse effect on the device's quality.
21 CFR 820.30(e). Design review - Lack of or inadequate procedures Procedures for design review have not been adequately established.
21 CFR 820.75(a). Documentation Process validation activities and results have not been adequately documented.
21 CFR 820.30(f). Design verification - Lack of or inadequate procedures Procedures for design verification have not been adequately 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 820.30(h). Design transfer - Lack of or inadequate procedures Procedures for design transfer have not been adequately established.
21 CFR 820.30(g). Design validation - production units The design was not validated under defined operating conditions and using initial production units, lots or batches or their equivalents.
21 CFR 820.75(a). Documentation Process validation activities and results have not been adequately documented and adequately approved.
21 CFR 820.22. Quality audits - auditor independence Individuals who conduct quality audits have direct responsibility for the matters being audited.
21 CFR 820.130. Packaging Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration or damage during processing, storage, handling, and distribution.
21 CFR 820.30(j). Design history file The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
21 CFR 806.10(a)(2). Report of violation of the Act (see 803.52(e)(9)) A violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA.
21 CFR 820.72(a). Equipment control activity documentation Equipment calibrations have not been documented.
21 CFR 820.22. Quality audits - Lack of or inadequate procedures Procedures for conducting quality audits were not complete.
21 CFR 820.250(a). Statistical techniques - Lack of or inadequate procedures Procedures to identify valid statistical techniques needed for certain product analyses have not been established.
21 CFR 820.70(a)(2). Production monitoring and control During production, process parameters are not monitored and controlled.
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
Wixom, Michigan, United States. Part of