FDA Inspection 786642 — Waters Medical Systems, LLC
The FDA completed an inspection of Waters Medical Systems, LLC on June 15, 2012 in Rochester, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 15, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rochester, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14719 | 21 CFR 820.30(h) | Incorrect translation to production specifications |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |