937368
Innovative Sterilization Technologies LLC — FEI 3010772758
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 13, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Dayton, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4192 | 21 CFR 806.10(a)(2) | Report of violation of the Act (see 803.52(e)(9)) |