Company
United StatesFresenius Medical Care Holdings, Inc., Waltham, MA – FDA Inspections
Inspection records and compliance data for Fresenius Medical Care Holdings, Inc. in Waltham, Massachusetts. 10 FDA inspections on record (4 OAI), 5 Form 483s, last inspected June 03, 2026.
Company Profile
This profile covers Fresenius Medical Care Holdings, Inc. based in Waltham, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 4
- VAI
- 2
- NAI
- 2
- Unclassified
- 2
- Form 483s
- 5
- Warning letters
- 0
First inspected August 6, 2010. Last inspected June 3, 2026.
Most cited issue areas
- Lack of or inadequate procedures4 inspections
- Report of Death or Serious Injury3 inspections
- Design changes - Lack of or Inadequate Procedures2 inspections
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 3, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1322950 |
| October 16, 2024 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1237243 |
| August 2, 2023 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1214802 |
| August 2, 2019 | NAI | Human Drugs, Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1098363 |
| January 12, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1037657 |
| October 19, 2017 | Not classified | Medical Devices & Rad Health | 1051942 |
| August 7, 2015 | NAI | Human Drugs, Medical Devices & Rad Health · Bioresearch Monitoring | 940091 |
| February 21, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 817769 |
| November 10, 2011 | OAI | Human Drugs, Medical Devices & Rad Health · Postmarket Assurance: Devices | 749130 |
| August 6, 2010 | OAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 667372 |
FDA documents
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Company Information
Name
Fresenius Medical Care Holdings, Inc.
FEI Number
3001451489
Address
920 Winter St Bld 920, Waltham, Massachusetts 02451, United States
Country
United States
ID: 71c8f1ab-77b5-4c59-ad13-3f0de5b7a6f3