FDA Inspection
Independent Chemical CorporationIndependent Chemical Corporation – FDA Inspection, Jan 29, 2016
Record Details
This FDA Inspection record concerns Independent Chemical Corporation, with an inspection on January 29, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 29, 2016
- Product Type
- Drugs
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ID · 384efe8c-aec4-4faa-89fc-f7fa7922ab2e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 956469
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Independent Chemical Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 10, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 12, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 4, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Independent Chemical Corporation
- FDA Inspection 798843 - 2012-09-13
- FDA Inspection 728697 - 2011-06-10
- FDA Inspection 627407 - 2009-11-12
- FDA Inspection 602047 - 2009-08-04
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