FDA Inspection 541038 — VertiFlex, Inc.
The FDA completed an inspection of VertiFlex, Inc. on October 7, 2008 in Carlsbad, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 7, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Carlsbad, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3141 | 21 CFR 820.150(a) | Storage procedures to prevent mix-ups |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3250 | 21 CFR 820.72(b)(2) | Calibration documentation |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 538 | 21 CFR 820.70(a) | Process control procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |