FDA Inspection 890571 — Linde Gas & Equiment Inc.
The FDA completed an inspection of Linde Gas & Equiment Inc. on Aug 8, 2014 in Tonawanda, NY. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 8, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Tonawanda, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |