Sartorius Stedim North America, Inc. FDA Record
Sartorius Stedim North America, Inc. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Sartorius Stedim North America, Inc." is on file.
- Latest inspection
- Jun 23, 2023 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Reviewing Sartorius Stedim North America, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Sartorius Stedim North America, Inc. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 23, 2023 | Cambridge, MA | Drugs | Voluntary Action Indicated (VAI) | 3013367666 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3013367666 | Cambridge, MA | 1 | Jun 23, 2023 |
Sartorius Stedim North America, Inc. and the FDA: common questions
Has Sartorius Stedim North America, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Sartorius Stedim North America, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Sartorius Stedim North America, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Sartorius Stedim North America, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Sartorius Stedim North America, Inc.?
The most recent FDA inspection on file ended Jun 23, 2023 at Cambridge, MA and was classified VAI. FDA has 1 inspection of Sartorius Stedim North America, Inc. on file.
Need more than this page shows? Ask about Sartorius Stedim North America, Inc. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.