FDA Inspection 1134103 — Cambridge Isotope Laboratories, Inc.
The FDA completed an inspection of Cambridge Isotope Laboratories, Inc. on Dec 9, 2020 in Tewksbury, MA. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 9, 2020
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tewksbury, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17763 | 21 CFR 212.20(d) | Determination need for investigation |
| 17770 | 21 CFR 212.40(a) | Suitable for intended use |
| 17773 | 21 CFR 212.40(b) | Written specifications - containers and closures |
| 17812 | 21 CFR 212.50 | Adequate controls (general) |