FDA Inspection 1277045 — Omega Biological Laboratories Inc.
The FDA completed an inspection of Omega Biological Laboratories Inc. on July 31, 2025 in Lyndhurst, NJ. 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
- July 31, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lyndhurst, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |