FDA Inspection 573015 — Medela Inc
The FDA completed an inspection of Medela Inc on April 2, 2009 in Mchenry, IL. 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
- April 2, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mchenry, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 2601 | 21 CFR 820.30(d) | Essential design outputs |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |