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FDA establishment 3003693105, Grand Rapids, Michigan, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 7
Official action indicated: 0
Last inspection ended: Nov 18, 2022
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 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which 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 211.22(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 211.56(c). Written procedures lacking for use of pesticides etc. Written procedures are lacking for the use of cleaning and sanitizing agents designed to prevent the contamination of components, drug product containers, closures and packaging, labeling materials.
Voluntary Action Indicated (VAI)
Oct 27, 2017
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Nov 7, 2014
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Dec 21, 2012
Drugs · Drug Quality Assurance
2 cited references
21 CFR 211.110(a). Written in-process control procedures Written procedures are not established and followed that describe the examinations to be conducted on appropriate samples of in-process materials of each batch.
21 CFR 211.188(b)(12). Investigations made into any unexplained discrepancy Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed.
Voluntary Action Indicated (VAI)
Nov 7, 2011
Drugs · Drug Quality Assurance
10 cited references
21 CFR 211.170(b). Annual visual exams of drug products Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
21 CFR 211.84(d)(2). Reports of Analysis (Components) Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
21 CFR 211.110(b). In-process materials specifications In-process specifications are not derived from previous acceptable process average and process variability estimates where possible.
21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which 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 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.111. Establishment of time limitations Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
21 CFR 211.110(a). Written in-process control procedures Written procedures are not followed that describe the tests to be conducted on appropriate samples of in-process materials of each batch.
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 211.84(d)(2). Testing Each Component for Conformity with Specs Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
21 CFR 211.192. Extent of discrepancy, failure investigations Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy.
Voluntary Action Indicated (VAI)
Oct 29, 2010
Drugs · Drug Quality Assurance
3 cited references
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
21 CFR 211.100(b). Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not recorded and justified.
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
Grand Rapids, Michigan, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.