FDA Inspection 1074810 — Laboratory Service Inc.
The FDA completed an inspection of Laboratory Service Inc. on Dec 18, 2018 in Carteret, NJ. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 18, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carteret, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |