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  5. Hanlim Pharm Co., Ltd., Yonginsi Ceoin-gu, Korea (the Republic of) – FDA Inspections
Company
•Korea (the Republic of)

Hanlim Pharm Co., Ltd., Yonginsi Ceoin-gu, Korea (the Republic of) – FDA Inspections

Inspection records and compliance data for Hanlim Pharm Co., Ltd. in Yonginsi Ceoin-gu. 6 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected April 24, 2026.

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Company Profile

This profile covers Hanlim Pharm Co., Ltd. based in Yonginsi Ceoin-gu, Korea (the Republic of).

FDA Inspection History

FDA inspections
6
OAI
1
VAI
3
NAI
0
Unclassified
2
Form 483s
2
Warning letters
1

First inspected April 18, 2014. Last inspected April 24, 2026.

Most cited issue areas

  • Procedures for sterile drug products3 inspections
  • Environmental Monitoring System2 inspections
  • Following/documenting laboratory controls2 inspections

FDA inspections (6)

DateResultFDA center(s)Insp. #
April 24, 2026Not classifiedHuman Drugs · Drug Quality Assurance1313712
April 10, 2026Not classifiedHuman Drugs1316122
May 31, 2022VAIHuman Drugs · Drug Quality Assurance1171848
February 6, 2018OAIHuman Drugs · Drug Quality Assurance1039954
July 19, 2016VAIHuman Drugs · Drug Quality Assurance985577
April 18, 2014VAIHuman Drugs · Drug Quality Assurance879041
FDA documents

Form 483s (3)

  • Form 483s · April 24, 2026
  • Form 483s · May 31, 2022
  • Form 483s · February 6, 2018

Warning Letters (1)

  • Warning Letters · April 24, 2026
People (4)
Rachel C. Harrington
Person
Truong X. Nguyen
Person
Hung H. Do
Person
Justin A. Boyd
Person
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Englewood Lab Korea Co., Ltd.
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Company Information

Name

Hanlim Pharm Co., Ltd.

FEI Number

3004886113

Address

2-27 Yeongmun-ro, Yonginsi Ceoin-gu, Korea (the Republic of)

Country

Korea (the Republic of)

ID: 2d7a6160-8193-4d7a-b9bd-569bfcbf933f

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