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•Korea (the Republic of)

Kovas Co., Ltd., Paju, Korea (the Republic of) – FDA Inspections

Inspection records and compliance data for Kovas Co., Ltd. in Paju. 2 FDA inspections on record, 1 Form 483, last inspected November 29, 2024.

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Company Profile

This profile covers Kovas Co., Ltd. based in Paju, Korea (the Republic of).

FDA Inspection History

FDA inspections
2
OAI
0
VAI
2
NAI
0
Form 483s
1
Warning letters
0

First inspected November 22, 2019. Last inspected November 29, 2024.

Most cited issue areas

  • Cleaning / Sanitizing / Maintenance2 inspections
  • Computer control of master formula records2 inspections
  • Procedures not in writing, fully followed2 inspections

FDA inspections (2)

DateResultFDA center(s)Insp. #
November 29, 2024VAIHuman Drugs · Drug Quality Assurance1255462
November 22, 2019VAIHuman Drugs · Drug Quality Assurance1111786
FDA documents

Form 483s (2)

  • Form 483s · November 29, 2024
  • Form 483s · November 22, 2019

EIRs (2)

  • EIRs · November 29, 2024
  • EIRs · November 22, 2019
People (4)
Christopher D. Leach
Person
Yasamin Ameri
Person
Sook-Yang Ko
Person
Joseph A. Piechocki
Person
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Company Information

Name

Kovas Co., Ltd.

FEI Number

3009640188

Address

43 Sinchon-Ro, Paju, Korea (the Republic of)

Country

Korea (the Republic of)

ID: 3fa71e84-4ee0-4ce4-97e5-4d2b4e5e71d2

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