FDA Inspection
Vitaminerals, Inc.Vitaminerals, Inc. – FDA Inspection, Dec 23, 2016
Record Details
This FDA Inspection record concerns Vitaminerals, Inc., with an inspection on December 23, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · fe558f07-bbd1-4f41-a2ea-65d33420ff5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 996807
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.100(a)Approval and review of procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vitaminerals, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 6, 2016 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 17, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 20, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 4, 2009 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Vitaminerals, Inc.
- FDA Inspection 970538 - 2016-05-06
- FDA Inspection 796009 - 2012-08-17
- FDA Inspection 721758 - 2011-04-20
- FDA Inspection 586437 - 2009-06-04
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.