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FDA establishment 3005482889, Lindon, Utah, United States. Part of MBi Nutraceuticals's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 1
Official action indicated: 1
Last inspection ended: Jan 12, 2018
Warning letters: 0
Recalls since 2016: 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.
Drugs · Drug Quality AssuranceDrugs · Unapproved and Misbranded Drugs
12 cited references
21 CFR 211.184(c). Individual inventory record Records fail to include an individual inventory record of each component and reconciliation of the use of each component with sufficient information to allow determination of any associated batch or lot of 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 211.166(c)(1). Homeopathic drugs, assessment of stability There is no written assessment of stability of homeopathic drug products based at least on testing or examination of the drug product for compatibility of the ingredients and marketing experience with the drug product to indicate that there is no degradation of the product for the normal or expected period of use.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine calibration, inspection and checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.
21 CFR 211.194(a)(4). Complete Test Data Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
21 CFR 211.125(a). Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.184(b). Component Test Records The component records do not include the results of tests or examinations performed and the conclusions derived from tests or examinations performed.
21 CFR 211.182. Written records kept in individual logs Written records of major equipment cleaning, maintenance and use are not included in individual equipment logs.
21 CFR 211.84(d)(2). Establish reliability of supplier's C of A Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Official Action Indicated (OAI)
Recalls
1 drug, device and biologic recalls since 2016, newest first; 0 Class I
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
Lindon, Utah, United States. Part of