1042022
Novel Laboratories, Inc. d.b.a Lupin Somerset — FEI 3006271438
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 23, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Somerset, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |