FDA Inspection 951140 — The Flexite Company
The FDA completed an inspection of The Flexite Company on Nov 19, 2015 in Mineola, NY. 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
- Nov 19, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mineola, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |