FDA Inspection
Cayman Chemical Company, Inc.Cayman Chemical Company, Inc. – FDA Inspection, May 18, 2009
Record Details
This FDA Inspection record concerns Cayman Chemical Company, Inc., with an inspection on May 18, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 18, 2009
- Product Type
- Drugs
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ID · 72b6dea6-76be-4221-83d1-586b8511c118
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 583096
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
14- 21 CFR 312.61Unauthorized recipients (investigator)
- 21 CFR 312.66Initial and continuing review
- 21 CFR 312.50General responsibilities of sponsors
- 21 CFR 312.59Records of unused drug disposition
- 21 CFR 50.25(a)(6)Compensation, medical treatment in event of injury
- 21 CFR 312.62(a)Accountability records
- 21 CFR 50.20Exculpatory language, waiving of rights
- 21 CFR 50.20Circumstances of obtaining consent
- 21 CFR 50.25(a)(1)Statement of research, purpose, duration of participation
- 21 CFR 50.25(a)(8)Participation; refusal and discontinuance
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Other FDA inspections of Cayman Chemical Company, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 17, 2025 | Not classified | Detroit District Office | |
| December 3, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 19, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 28, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 22, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cayman Chemical Company, Inc.
- FDA Inspection 1267154 - 2025-04-17
- FDA Inspection 1074100 - 2018-12-03
- FDA Inspection 904339 - 2014-11-19
- FDA Inspection 820205 - 2013-02-28
- FDA Inspection 759917 - 2011-12-22
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