FDA Inspection 596268 — Axiom Worldwide,Inc.
The FDA completed an inspection of Axiom Worldwide,Inc. on Jul 10, 2009 in Tampa, 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 10, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3687 | 21 CFR 820.100(a)(1) | Analysis of data sources |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 538 | 21 CFR 820.70(a) | Process control procedures |