FDA Inspection
Elorac Inc.Elorac Inc. – FDA Inspection, Nov 14, 2012
Record Details
This FDA Inspection record concerns Elorac Inc., with an inspection on November 14, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Elorac Inc.
- Inspection Date
- November 14, 2012
- Product Type
- Drugs
View Company Profile
ID · 6c969dbb-6605-4f99-a5f6-07cf848d19fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 805979
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 111.610(a)Records - available; FDA
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Elorac Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 18, 2019 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| March 28, 2016 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| January 20, 2015 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| January 30, 2012 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Elorac Inc.
- FDA Inspection 1085697 - 2019-03-18
- FDA Inspection 965131 - 2016-03-28
- FDA Inspection 911687 - 2015-01-20
- FDA Inspection 765728 - 2012-01-30
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.