FDA Inspection 779907 — Medela Inc
The FDA completed an inspection of Medela Inc on May 25, 2012 in Mchenry, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 25, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mchenry, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1132 | 21 CFR 110.40(a) | Food-contact - unlawful indirect additives |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |