FDA Inspection 858432 — BTI Filtration
The FDA completed an inspection of BTI Filtration on Dec 12, 2013 in Oklahoma City, OK. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 12, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Oklahoma City, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |