FDA Inspection 672266 — American IV Products, Inc.
The FDA completed an inspection of American IV Products, Inc. on July 21, 2010 in Harmans, MD. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 21, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Harmans, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |