FDA Inspection 658929 — Danmar Products, Inc.
The FDA completed an inspection of Danmar Products, Inc. on Apr 12, 2010 in Ann Arbor, MI. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 12, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ann Arbor, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3332 | 21 CFR 820.184(e) | ID label, labeling |
| 3428 | 21 CFR 820.50(a)(3) | Acceptable supplier records |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |