SENTINEL CH. SPA FDA Inspection Record
SENTINEL CH. SPA is an FDA-registered facility (FEI 3000303338) located in MILANO Milano, IT. RegDataLab tracks 3 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Feb 22, 2018: No Action Indicated (NAI)
- Inspections on record
- 3 (3 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 6, latest Sep 29, 2023
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 22, 2018 | No Action Indicated (NAI) | No citations listed |
| Sep 22, 2016 | No Action Indicated (NAI) | No citations listed |
| Jun 1, 2011 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Sep 29, 2023 | Class II | Z-0325-2024 | IRON assay, Reference Numbers 6K95-41 and 6K95-30 and 1 more product A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control… |
| Jul 29, 2021 | Class III | Z-0033-2022 | Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage… Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators… |
| Apr 30, 2021 | Class III | Z-2012-2021 | ACE Control Set - IVD Control set for the quantitative determination of Angiotensin… Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. New IFU instructions for… |
| Jun 28, 2019 | Class II | Z-2551-2019 | MULTIGENT Lithium-intended for the quantitation of lithium in
serum or plasma using… and 1 more product Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent… |
| May 22, 2017 | Class II | Z-2867-2017 | MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for… Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration. |
| Sep 22, 2015 | Class II | Z-0164-2016 | Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement… Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes. |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
Reviewing SENTINEL CH. SPA 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 SENTINEL CH. SPA yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Facility details
- Company
- Sentinel CH SpA
- Location
- MILANO Milano (IT)
- Source
- device