FDA Inspection 615769 — Sanatmetal LTD.
The FDA completed an inspection of Sanatmetal LTD. on September 17, 2009 in Eger. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 17, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Eger (Hungary)
Citations
| ID | CFR | Description |
|---|---|---|
| 2600 | 21 CFR 820.30(d) | Acceptance criteria not identified |
| 2649 | 21 CFR 820.30(f) | Design verification acceptance criteria |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3284 | 21 CFR 820.90(a) | Nonconforming product evaluation/investigation |
| 3689 | 21 CFR 820.100(a)(2) | Investigation |
| 3841 | 21 CFR 820.90(b)(2) | Product rework adverse effects {see also 820.184} |