FDA Inspection 818056 — Ohio Valley Acquisition Corp.
The FDA completed an inspection of Ohio Valley Acquisition Corp. on Jan 31, 2013 in Evansville, 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 31, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Evansville, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |