FDA Inspection
Fresenius Medical Care Holdings, Inc.Fresenius Medical Care Holdings, Inc. – FDA Inspection, Aug 6, 2010
Record Details
This FDA Inspection record concerns Fresenius Medical Care Holdings, Inc., with an inspection on August 6, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 6, 2010
- Product Type
- Drugs
View Company Profile
ID · 94318dce-a1da-41fd-b186-1349210c32e0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 667372
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
17- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 820.198(a)General
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(a)Complete files maintained
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.90(a)Specific non-conforming product procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
Showing 10 of 17 citations.
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Other FDA inspections of Fresenius Medical Care Holdings, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| June 3, 2026 | Not classified | New England District Office | Compliance: Devices |
| October 16, 2024 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 2, 2023 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 2, 2019 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| January 12, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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