FDA Inspection 1066151 — American IV Products, Inc.
The FDA completed an inspection of American IV Products, Inc. on September 12, 2018 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
- September 12, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Harmans, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |