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21 CFR 211.67(b). Written procedures fail to include Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used and parameters relevant to the operation.
21 CFR 211.198(b). Written complaint record to be maintained at facility A written record of each complaint is not maintained in a file designated for drug product complaints at the facility where the drug product was manufactured, processed or packed.
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.
Voluntary Action Indicated (VAI)
Sep 12, 2024
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Mar 4, 2016
Drugs · Drug Quality AssuranceDrugs · Unapproved and Misbranded Drugs
2 cited references
21 CFR 211.103. Actual vs. theoretical yields not determined Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of packaging of 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.
Voluntary Action Indicated (VAI)
Jan 18, 2013
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Mar 11, 2011
Drugs · Drug Quality Assurance
10 cited references
21 CFR 211.188. Prepared for each batch, include complete information Batch production and control records do not include complete information relating to the production and control of each batch.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine calibration, inspection, and checking of automatic, mechanical, and electronic equipment is not performed according to a written program designed to assure proper performance.
21 CFR 211.80(a). Written Procedures Not Followed Written procedures are not followed for the identification and storage of components.
21 CFR 211.192. No written record of investigation Written records are not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.
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 211.125(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 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
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.
21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
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
Draper, Utah, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.