NARVA Lichtquelle GmbH + Co. KG — FDA Facility Profile
NARVA Lichtquelle GmbH + Co. KG is an FDA-inspected facility (FEI 3002553648) located in Berlin, DE. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Feb 22, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (1 OAI, 2 VAI)
- Last OAI inspection
- Jul 29, 2016
- Warning letters
- 1 listed by FDA for this FEI, latest Feb 23, 2017
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 22, 2023 | Voluntary Action Indicated (VAI) | Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a)) |
| Sep 28, 2017 | Voluntary Action Indicated (VAI) | Documentation (21 CFR 820.80(e)) Not approved or obsolete document retrieval (21 CFR 820.40(a)) Sampling plans (21 CFR 820.250(b)) Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a)) |
| Jul 29, 2016 | Official Action Indicated (OAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design control - no procedures (21 CFR 820.30(a)) Buildings (21 CFR 820.70(f)) Nonconforming product control (21 CFR 820.90(a)) and 6 more |
Facility details
- Company
- NARVA Lichtquelle GmbH + Co. KG
- Location
- Berlin (DE)
- Source
- inspections