FDA Inspection 1147635 — Teleflex LLC (NADC)
The FDA completed an inspection of Teleflex LLC (NADC) on July 30, 2021 in Olive Branch, MS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 30, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Olive Branch, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3699 | 21 CFR 820.160(b) | Distribution records |
| 3837 | 21 CFR 820.25(b) | Training records |