MUELLER SPORTS MEDICINE, INC. FDA Inspection Record
MUELLER SPORTS MEDICINE, INC. is an FDA-registered facility (FEI 2110420) located in PRAIRIE DU SAC, WI, US. RegDataLab tracks 7 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Apr 3, 2025: No Action Indicated (NAI)
- Inspections on record
- 7 (2 VAI, 5 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
- 1, latest Jun 18, 2020
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 3, 2025 | No Action Indicated (NAI) | No citations listed |
| Mar 11, 2019 | No Action Indicated (NAI) | No citations listed |
| Apr 20, 2016 | No Action Indicated (NAI) | No citations listed |
| Dec 5, 2013 | Voluntary Action Indicated (VAI) | Contract drug products--lack of responsibility (21 CFR 211.22(a)) Specifications met - quality (21 CFR 111.73) |
| Sep 6, 2012 | Voluntary Action Indicated (VAI) | Contract drug products--lack of responsibility (21 CFR 211.22(a)) Approve or reject procedures or specs (21 CFR 211.22(c)) Batch record - component; unique identifier (21 CFR 111.260(d)) Hold - temperature, humidity, light (21 CFR 111.455(a)) and 4 more |
| Apr 21, 2011 | No Action Indicated (NAI) | No citations listed |
| Apr 23, 2009 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jun 18, 2020 | Class II | Z-2475-2020 | Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex". |
FDA record score
1 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
3 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class II recall Z-2475-2020, this FEI as the recalling firm | Jun 18, 2020 | 4 x 0.25 | 1 |
| Inspection classified VAI | Dec 5, 2013 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Sep 6, 2012 | 10 years or older, so it adds no points | 0 |
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 |
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Facility details
- Company
- Mueller Sports Medicine, Inc
- Location
- PRAIRIE DU SAC, WI (US)
- Source
- device