FDA Inspection 874521 — Ammar Apparel II de R.L. de C.V
The FDA completed an inspection of Ammar Apparel II de R.L. de C.V on April 9, 2014 in Pueblo Tepakan. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 9, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pueblo Tepakan (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3671 | 21 CFR 820.25(a) | Personnel |