FDA Inspection
Indiana Botanic Gardens, IncIndiana Botanic Gardens, Inc – FDA Inspection, Mar 27, 2015
Record Details
This FDA Inspection record concerns Indiana Botanic Gardens, Inc, with an inspection on March 27, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Indiana Botanic Gardens, Inc
- Inspection Date
- March 27, 2015
- Product Type
- Drugs
View Company Profile
ID · 416414a5-4df9-471f-8dca-80e1a9a11640
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 919859
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.67(b)Written procedures fail to include
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Indiana Botanic Gardens, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2025 | VAI | Detroit District Office | Drug Quality Assurance |
| March 23, 2018 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 11, 2009 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Indiana Botanic Gardens, Inc
- FDA Inspection 1284968 - 2025-09-30
- FDA Inspection 1045431 - 2018-03-23
- FDA Inspection 605744 - 2009-08-11
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