FDA Inspection
United Guardian IncUnited Guardian Inc – FDA Inspection, Sep 4, 2025
Record Details
This FDA Inspection record concerns United Guardian Inc, with an inspection on September 4, 2025, issued by the New York District Office, covering human drugs.
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ID · 741f8584-8ac3-4dba-976a-ce8d5a6c621b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1280962
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.68(b)Written record not kept of program and validation data
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of United Guardian Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2024 | VAI | New York District Office | Postmarketing Surveillance and Epidemiology: Human Drugs |
| 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 |
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