FDA Inspection
Fresenius Medical Care, North AmericaFresenius Medical Care, North America – FDA Inspection, May 21, 2021
Record Details
This FDA Inspection record concerns Fresenius Medical Care, North America, with an inspection on May 21, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 21, 2021
- Product Type
- Drugs
View Company Profile
ID · db66591a-8daf-4506-8be5-9880c32cc538
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1142311
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fresenius Medical Care, North America
11| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2026 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 6, 2026 | Not classified | Denver District Office | Drug Quality Assurance |
| August 13, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 18, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 18, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Fresenius Medical Care, North America
- FDA Inspection 1330254 - 2026-07-24
- FDA Inspection 1305990 - 2026-03-06
- FDA Inspection 1126818 - 2020-08-13
- FDA Inspection 1023304 - 2017-08-18
- FDA Inspection 1015295 - 2017-05-18
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.