FDA Inspection
EarthLab Holdings IncEarthLab Holdings Inc – FDA Inspection, Sep 30, 2016
Record Details
This FDA Inspection record concerns EarthLab Holdings Inc, with an inspection on September 30, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- EarthLab Holdings Inc
- Inspection Date
- September 30, 2016
- Product Type
- Drugs
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ID · 99cd2bac-52bf-47d0-a1ca-53688973515d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 989601
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.198(b)(3)Reason for Not Conducting Complaint Investigation
- 21 CFR 211.115(a)Reprocessing procedures lack steps to be taken
- 21 CFR 211.186(b)(2)Name, weight of active ingredient; total weight or measure
- 21 CFR 211.180(e)(2)Review of problem drugs
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Other FDA inspections of EarthLab Holdings Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 8, 2024 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 24, 2023 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 14, 2022 | OAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| August 26, 2019 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| June 21, 2013 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
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