Sunshine USA, LLC FDA Inspection Record
Sunshine USA, LLC is an FDA-registered facility (FEI 3009973354) located in JC, TN, US. RegDataLab tracks 7 FDA inspections and 2 compliance actions at this facility.
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What FDA found at this site
- Latest inspection
- Apr 28, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 7 (2 OAI, 4 VAI, 1 NAI)
- Last OAI inspection
- Jun 14, 2013
- Warning letters
- 2 listed by FDA for this FEI, latest Dec 5, 2013
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 28, 2025 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Training - Lack of or inadequate procedures (21 CFR 820.25(b)) Lack of or inadequate procedures (21 CFR 820.100(a)) Calibration, Inspection, etc. Procedures Lack of or Inadequ (21 CFR 820.72(a)) |
| Aug 17, 2023 | No Action Indicated (NAI) | DHR - not or inadequately maintained (21 CFR 820.184) Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Training - Lack of or inadequate procedures (21 CFR 820.25(b)) Calibration, Inspection, etc. Procedures Lack of or Inadequ (21 CFR 820.72(a)) and 2 more |
| Nov 19, 2015 | Voluntary Action Indicated (VAI) | DHR - not or inadequately maintained (21 CFR 820.184) Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Acceptable supplier records, inadequate records (21 CFR 820.50(a)(3)) Quality audits - Lack of or inadequate procedures (21 CFR 820.22) and 10 more |
| Jun 14, 2013 | Official Action Indicated (OAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Quality audits - Lack of or inadequate procedures (21 CFR 820.22) Lack of or inadequate In-process acceptance procedures (21 CFR 820.80(c)) Lack of or inadequate final acceptance procedures (21 CFR 820.80(d)) and 10 more |
| Jan 25, 2012 | Official Action Indicated (OAI) | Quality System Procedures (21 CFR 820.20(e)) Failure to submit (21 CFR 1002.11) Failure to submit (21 CFR 1002.13) Certification not based on adequate test/testing program (21 CFR 1010.2(c)) and 1 more |
| Mar 4, 2011 | Voluntary Action Indicated (VAI) | No citations listed |
| Jan 15, 2010 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- Sunshine USA, LLC
- Location
- JC, TN (US)
- Source
- device