FDA Inspection 579641 — Medical Accessories, Inc.
The FDA completed an inspection of Medical Accessories, Inc. on Apr 30, 2009 in Trenton, NJ. 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
- Apr 30, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Trenton, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3157 | 21 CFR 820.181(c) | DMR QA procedures and specifications |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 4189 | 21 CFR 820.198(a) | General |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |