Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
21 CFR 211.68(b). input/output verification Input to and output from related systems of formulas and records or data are not checked for accuracy.
21 CFR 211.194(a). Complete test data included in records Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
Voluntary Action Indicated (VAI)
Jul 19, 2024
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Feb 7, 2018
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 in writing and fully followed.
21 CFR 211.194(a). Complete test data included in records Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine checking of electronic equipment is not performed according to a written program designed to assure proper performance. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Voluntary Action Indicated (VAI)
May 4, 2015
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Apr 8, 2013
Drugs · Drug Quality Assurance
1 cited reference
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.
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
Oakdale, Minnesota, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.