FDA Inspection 667372 — Fresenius Medical Care Renal Therapies Group, LLC
The FDA completed an inspection of Fresenius Medical Care Renal Therapies Group, LLC on August 6, 2010 in Waltham, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 17 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 6, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Waltham, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3283 | 21 CFR 820.90(a) | Specific non-conforming product procedures |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 4189 | 21 CFR 820.198(a) | General |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |