FDA Inspection 1006295 — Tekna Manufacturing, LLC
The FDA completed an inspection of Tekna Manufacturing, LLC on Feb 28, 2017 in Zephyrhills, FL. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 28, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Zephyrhills, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3837 | 21 CFR 820.25(b) | Training records |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |