FDA Inspection
Old Fashioned Natural Products IncOld Fashioned Natural Products Inc – FDA Inspection, Jan 13, 2011
Record Details
This FDA Inspection record concerns Old Fashioned Natural Products Inc, with an inspection on January 13, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 13, 2011
- Product Type
- Drugs
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ID · bda5b5df-5cd6-469f-9947-5c459042bea6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 705407
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
19- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 111.12(c)Personnel - education, training, experience
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of Old Fashioned Natural Products Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 17, 2023 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 27, 2012 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 27, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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