FDA Inspection 585881 — Steritec Products Mfg. Co., Inc.
The FDA completed an inspection of Steritec Products Mfg. Co., Inc. on Jun 2, 2009 in Englewood, CO. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 2, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Englewood, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 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 |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3837 | 21 CFR 820.25(b) | Training records |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |