FDA Inspection 946338 — ONY Biotech, Inc.
The FDA completed an inspection of ONY Biotech, Inc. on October 9, 2015 in Amherst, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 9, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Amherst, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3548 | 21 CFR 211.46(c) | Air filtration system lacking in production area |