FDA Inspection 1158889 — Invahealth Inc.
The FDA completed an inspection of Invahealth Inc. on Dec 15, 2021 in Cranbury, 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 15, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cranbury, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 4330 | 21 CFR 211.130(e) | Packaging line inspection documentation |