FDA Inspection 625589 — Pennatek LLC
The FDA completed an inspection of Pennatek LLC on October 7, 2009 in Sheridan, IN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 7, 2009
- Fiscal Year
- 2010
- Product Type
- Veterinary
- Project Area
- Bioresearch Monitoring
- Location
- Sheridan, IN (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 13526 | 21 CFR 511.1(b)(8)(ii) | Sponsor/CRO: Reporting of hazards |
| 3900 | 21 CFR 58.10 | Notifying contractor of GLP status |
| 3920 | 21 CFR 58.33(c) | Study director: unforeseen circumstances |