FDA Inspection 602130 — Steripac
The FDA completed an inspection of Steripac on July 30, 2009 in Birmingham, AL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 30, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Birmingham, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3156 | 21 CFR 820.181(b) | DMR production process specifications |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3283 | 21 CFR 820.90(a) | Specific non-conforming product procedures |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |