FDA Inspection
H2O Plus, LLCH2O Plus, LLC – FDA Inspection, Nov 10, 2009
Record Details
This FDA Inspection record concerns H2O Plus, LLC, with an inspection on November 10, 2009, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- H2O Plus, LLC
- Inspection Date
- November 10, 2009
- Product Type
- Food/cosmetics
View Company Profile
ID · eeb867fb-0673-4a2c-a1bf-f9232aa7d629
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 625632
- FDA center
- Foods & Cosmetics
- Project area
- Colors and Cosmetics Technology
FDA Citations
15- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.25(c)Inadequate number of personnel
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of H2O Plus, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 29, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 |
Other documents for H2O Plus, LLC
- FDA Inspection 863028 - 2014-01-29
- FDA Inspection 741910 - 2011-08-22
- FDA Inspection 683292 - 2010-09-30
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