FDA Inspection 996370 — Tedec-Meiji Farma, S.A.
The FDA completed an inspection of Tedec-Meiji Farma, S.A. on Dec 15, 2016 in Alcala de Henares. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 15, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Alcala de Henares (Spain)
Additional details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 537 | 21 CFR 820.70(a) | Production processes |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |