FDA Inspection 554943 — Danmar Products, Inc.
The FDA completed an inspection of Danmar Products, Inc. on Jan 15, 2009 in Ann Arbor, MI. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 13 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 15, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ann Arbor, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3157 | 21 CFR 820.181(c) | DMR QA procedures and specifications |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |