FDA Inspection
Coram Healthcare Corp. of IndianaCoram Healthcare Corp. of Indiana – FDA Inspection, Dec 16, 2014
Record Details
This FDA Inspection record concerns Coram Healthcare Corp. of Indiana, with an inspection on December 16, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 16, 2014
- Product Type
- Drugs
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ID · a90eddf1-90b5-426e-a422-e06b26146278
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 907386
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Coram Healthcare Corp. of Indiana
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 26, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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