FDA Inspection 748464 — ONY Biotech, Inc.
The FDA completed an inspection of ONY Biotech, Inc. on October 6, 2011 in Amherst, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 6, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Amherst, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 6823 | 21 CFR 314.80(c) | Failure by applicant to report ADE |