FDA Inspection 1015589 — Rising Pharma Holdings, Inc
The FDA completed an inspection of Rising Pharma Holdings, Inc on Apr 26, 2017 in Decatur, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 26, 2017
- Fiscal Year
- 2017
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Decatur, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |