SUMMIT MEDICAL LLC FDA Inspection Record
SUMMIT MEDICAL LLC is an FDA-registered facility (FEI 3008719017) located in Saint Paul, MN, US. RegDataLab tracks 8 FDA inspections and 1 compliance action at this facility.
What FDA found at this site
- Latest inspection
- May 14, 2018: Voluntary Action Indicated (VAI)
- Inspections on record
- 8 (2 VAI, 6 NAI)
- Last OAI inspection
- None on record
- Warning letters
- 1 listed by FDA for this FEI, latest Apr 25, 2013
- Recalls as the recalling firm
- 4, latest Jan 13, 2023
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 14, 2018 | Voluntary Action Indicated (VAI) | Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b)) Equipment suitability & capability (21 CFR 820.72(a)) Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a)) Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50) and 2 more |
| Mar 9, 2018 | Voluntary Action Indicated (VAI) | Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b)) Lack of or inadequate procedures (21 CFR 820.100(a)) Lack of or inadequate process validation (21 CFR 820.75(a)) |
| Nov 10, 2016 | No Action Indicated (NAI) | Design output - Lack of or inadequate procedures (21 CFR 820.30(d)) Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i)) Documentation (21 CFR 820.80(e)) Lack of or inadequate procedures (21 CFR 820.100(a)) and 1 more |
| Mar 4, 2015 | No Action Indicated (NAI) | No citations listed |
| May 5, 2014 | No Action Indicated (NAI) | Documentation (21 CFR 820.75(a)) Nonconforming product control (21 CFR 820.90(a)) Documentation (21 CFR 820.100(b)) |
| Jan 28, 2013 | No Action Indicated (NAI) | Design verification - output does not meet input requirement (21 CFR 820.30(f)) Design review - Lack of or inadequate procedures (21 CFR 820.30(e)) Lack of or inadequate procedures - Acceptance activities (21 CFR 820.80(a)) Lack of or inadequate procedures (21 CFR 820.100(a)) and 7 more |
| Sep 7, 2012 | No Action Indicated (NAI) | Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b)) Lack of or inadequate In-process acceptance procedures (21 CFR 820.80(c)) |
| Nov 6, 2009 | No Action Indicated (NAI) | Quantity manufactured (21 CFR 820.184(b)) Equipment control activity documentation (21 CFR 820.72(a)) Documentation (21 CFR 820.80(c)) Nonconforming product evaluation/investigation (21 CFR 820.90(a)) and 1 more |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jan 13, 2023 | Class II | Z-1171-2023 | Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile. Sterile product pouches were not sealed. |
| Sep 3, 2015 | Class II | Z-0435-2016 | AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm… Summit Medical is recalling Doyle P/F Nasal Pack w/Airway, string 8 cm x 3 cm x 1.5 cm, Catalog # RH-7413-10, Lot # 160889 & 161354 because… |
| May 12, 2014 | Class II | Z-1731-2014 | Armstrong Grommet with wire Otological Ventilation Tube
Catalog #: VT-0507-01… One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the… |
| Mar 27, 2013 | Class II | Z-1319-2013 | Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical… Summit Medical has initiated a recall of Myringotomy Lance Blade (Juvenile) because the box contains the wrong blade. The box contains… |
FDA record score
5 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.
7 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class II recall Z-1171-2023, this FEI as the recalling firm | Jan 13, 2023 | 4 x 0.6 | 2.4 |
| Inspection classified VAI | May 14, 2018 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Mar 9, 2018 | 6 x 0.25 | 1.5 |
| Class II recall Z-0435-2016, this FEI as the recalling firm | Sep 3, 2015 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-1731-2014, this FEI as the recalling firm | May 12, 2014 | 10 years or older, so it adds no points | 0 |
| Warning letter on FDA's dashboard, which does not show close-outs | Apr 25, 2013 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-1319-2013, this FEI as the recalling firm | Mar 27, 2013 | 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 15, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 15, 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 15, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
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Facility details
- Company
- Summit Medical, LLC
- Location
- Saint Paul, MN (US)
- Source
- device