FDA Inspection 712649 — Rush & Hebble Co., Inc.
The FDA completed an inspection of Rush & Hebble Co., Inc. on Mar 4, 2011 in Edinburgh, IN. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 4, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Edinburgh, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |