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Niva Medical Oy, Espoo, Finland – FDA Inspections

Inspection records and compliance data for Niva Medical Oy in Espoo. 1 FDA inspection on record (1 OAI), 1 Form 483, last inspected September 15, 2017.

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Company Profile

This profile covers Niva Medical Oy based in Espoo, Finland.

FDA Inspection History

FDA inspections
1
OAI
1
VAI
0
NAI
0
Form 483s
1
Warning letters
0

Inspected September 15, 2017.

Most cited issue areas

  • Absence of Written Procedures1 inspection
  • Actual vs. theoretical yields not determined1 inspection
  • Contract drug products--lack of responsibility1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
September 15, 2017OAIHuman Drugs · Drug Quality Assurance1026499
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Company Information

Name

Niva Medical Oy

FEI Number

3007320708

Address

Olarinluoma 14 B, Espoo, Finland

Country

Finland

ID: 980345ac-e234-42e5-9374-7b9fe1afc7a8

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