FDA Inspection
H2O Plus, LLCH2O Plus, LLC – FDA Inspection, Jan 29, 2014
Record Details
This FDA Inspection record concerns H2O Plus, LLC, with an inspection on January 29, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- H2O Plus, LLC
- Inspection Date
- January 29, 2014
- Product Type
- Drugs
View Company Profile
ID · e0ffb033-d389-42ea-ae00-4422fbcf5929
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 863028
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of H2O Plus, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 30, 2010 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| November 10, 2009 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for H2O Plus, LLC
- FDA Inspection 741910 - 2011-08-22
- FDA Inspection 683292 - 2010-09-30
- FDA Inspection 625632 - 2009-11-10
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