FDA Inspection
New Spirit Naturals Inc.New Spirit Naturals Inc. – FDA Inspection, Sep 7, 2010
Record Details
This FDA Inspection record concerns New Spirit Naturals Inc., with an inspection on September 7, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- New Spirit Naturals Inc.
- Inspection Date
- September 7, 2010
- Product Type
- Drugs
View Company Profile
ID · 5c16d1ed-ba73-4b9f-9bba-861c558b66cf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 680644
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.188(b)(11)Identification of persons involved, each significant step
- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of New Spirit Naturals Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2025 | Not classified | Los Angeles District Office | Foodborne Biological Hazards |
| August 24, 2021 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| July 26, 2019 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 27, 2016 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 4, 2013 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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