FDA Inspection
United Guardian IncUnited Guardian Inc – FDA Inspection, Sep 5, 2024
Record Details
This FDA Inspection record concerns United Guardian Inc, with an inspection on September 5, 2024, issued by the New York District Office, covering human drugs.
View Company Profile
ID · c9b9b8c2-e672-41eb-a731-0dc7909356a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1249645
- FDA center
- Human Drugs
- Project area
- Postmarketing Surveillance and Epidemiology: Human Drugs
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 314.80(b)Failure to develop written procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of United Guardian Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2025 | VAI | New York District Office | Drug Quality Assurance |
| August 2, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 16, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 22, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 7, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for United Guardian Inc
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.