FDA Inspection 648376 — Medela Inc
The FDA completed an inspection of Medela Inc on January 21, 2010 in Mchenry, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 21, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mchenry, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |