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Upsher-Smith Laboratories, LLC

FDA establishment 3032948549, Maple Grove, Minnesota, United States. Part of Upsher-Smith Laboratories's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.

  • Inspections: 2
  • Official action indicated: 0
  • Last inspection ended: Feb 10, 2026
  • Warning letters: 0

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

Most Cited at This Site

Inspections citing each reference

Inspections

2 inspections, newest first
EndedProduct and areaCitationsClassification
Feb 10, 2026Drugs · Bioresearch MonitoringNone postedNo Action Indicated (NAI)
Aug 8, 2025Drugs · Bioresearch Monitoring
2 cited references
  • 21 CFR 314.80(c)(1)(i). Late submission of 15-day report Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
  • 21 CFR 314.80(b). Failure to develop written procedures Written procedures have not been developed for the surveillance and receipt of post marketing adverse drug experiences.
Voluntary Action Indicated (VAI)

Identifiers

FEI number
3032948549
FDA firm profile
Data Dashboard

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

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.