FDA Inspection
Fresenius USA Manufacturing, IncFresenius USA Manufacturing, Inc – FDA Inspection, Oct 6, 2017
Record Details
This FDA Inspection record concerns Fresenius USA Manufacturing, Inc, with an inspection on October 6, 2017, issued by the New Orleans District Office, covering human drugs.
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ID · 56e86173-71a4-416b-83ec-6bc5c4e27b4e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1028853
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.160(a)Deviations from laboratory control requirements
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Other FDA inspections of Fresenius USA Manufacturing, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2025 | Not classified | New Orleans District Office | |
| October 18, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 7, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 26, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 12, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Fresenius USA Manufacturing, Inc
- FDA Inspection 1284734 - 2025-09-19
- FDA Inspection 1251719 - 2024-10-18
- FDA Inspection 1195086 - 2022-12-07
- FDA Inspection 1124187 - 2020-06-26
- FDA Inspection 1110322 - 2019-09-12
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