FDA Inspection 583096 — Cayman Chemical Company, Inc.
The FDA completed an inspection of Cayman Chemical Company, Inc. on May 18, 2009 in Ann Arbor, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 18, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Ann Arbor, MI (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7387 | 21 CFR 50.25(a)(1) | Statement of research, purpose, duration of participation |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |
| 7392 | 21 CFR 50.25(a)(7) | Whom to contact |
| 7393 | 21 CFR 50.25(a)(8) | Participation; refusal and discontinuance |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7488 | 21 CFR 312.59 | Records of unused drug disposition |
| 7517 | 21 CFR 312.66 | Initial and continuing review |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7543 | 21 CFR 312.61 | Unauthorized recipients (investigator) |
| 7638 | 21 CFR 312.20(a) | Failure to submit an IND |
| 7657 | 21 CFR 50.25(b)(5) | Significant new findings |
| 7659 | 21 CFR 50.25(a)(6) | Compensation, medical treatment in event of injury |
| 7664 | 21 CFR 50.20 | Circumstances of obtaining consent |
| 7665 | 21 CFR 50.20 | Exculpatory language, waiving of rights |