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FDA establishment 3000913784, Grand Rapids, Michigan, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 1
Last inspection ended: Oct 29, 2024
Warning letters: 0
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 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
21 CFR 211.125(f). Procedures Written and Followed Procedures describing in sufficient detail the controls employed for the issuance of labeling are not written.
21 CFR 211.160(a). Lab controls established, including changes The establishment of specifications, standards, sampling plans, test procedures and laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
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
Grand Rapids, Michigan, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.