FDA Inspection 625749 — Flexbar Machine Corp
The FDA completed an inspection of Flexbar Machine Corp on October 30, 2009 in Islandia, NY. 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
- October 30, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Islandia, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 636 | 21 CFR 803.17(b)(2) | Reports and information documentation |