FDA Inspection
United Guardian IncUnited Guardian Inc – FDA Inspection, Jul 22, 2011
Record Details
This FDA Inspection record concerns United Guardian Inc, with an inspection on July 22, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- United Guardian Inc
- Inspection Date
- July 22, 2011
- Product Type
- Drugs
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ID · 35ec1576-ddd0-4770-b16c-f7d769f48e97
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 735615
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of United Guardian Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2025 | VAI | New York District Office | Drug Quality Assurance |
| 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 |
| April 7, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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