FDA Inspection 1081709 — Ralston Group
The FDA completed an inspection of Ralston Group on Mar 7, 2019 in Selma, AL. 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). 15 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 7, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Selma, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 14721 | 21 CFR 820.70(g)(2) | Periodic equipment inspections |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3837 | 21 CFR 820.25(b) | Training records |
| 3841 | 21 CFR 820.90(b)(2) | Product rework adverse effects {see also 820.184} |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |