FDA Inspection 1090850 — Etex Corporation
The FDA completed an inspection of Etex Corporation on May 23, 2019 in Braintree, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 23, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Braintree, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |