ELTECH K-LASER S.R.L. FDA Inspection Record
ELTECH K-LASER S.R.L. is an FDA-registered facility (FEI 3004642415) located in TREVISO Treviso, IT. RegDataLab tracks 2 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Aug 29, 2014: Official Action Indicated (OAI)
- Inspections on record
- 2 (1 OAI, 1 VAI)
- Last OAI inspection
- Aug 29, 2014
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 2
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Aug 29, 2014 | Official Action Indicated (OAI) | Design validation- Lack of or inadequate procedures (21 CFR 820.30(g)) Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i)) Nonconforming product control (21 CFR 820.90(a)) |
| Dec 9, 2010 | Voluntary Action Indicated (VAI) | DHR - not or inadequately maintained (21 CFR 820.184) Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Management review - Lack of or inadequate procedures (21 CFR 820.20(c)) Documentation (21 CFR 820.100(b)) and 3 more |
Facility details
- Company
- Eltech S.R.L.
- Location
- TREVISO Treviso (IT)
- Source
- device