FDA Inspection
Sensible Organics, Inc.Sensible Organics, Inc. – FDA Inspection, Feb 9, 2012
Record Details
This FDA Inspection record concerns Sensible Organics, Inc., with an inspection on February 9, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sensible Organics, Inc.
- Inspection Date
- February 9, 2012
- Product Type
- Drugs
View Company Profile
ID · dc538fe9-12db-47e0-ab9f-9a6d2335650f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 765827
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
15- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.188(b)(4)Weights and measures of components used
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.194(a)(1)Sample identification and other information
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
Showing 10 of 15 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sensible Organics, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 17, 2016 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| May 11, 2016 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| July 25, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 16, 2011 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for Sensible Organics, Inc.
- FDA Inspection 983878 - 2016-08-17
- FDA Inspection 972654 - 2016-05-11
- FDA Inspection 841554 - 2013-07-25
- FDA Inspection 734165 - 2011-06-16
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.