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Guilin Pharmaceutical Co., Ltd., Guilin, China – FDA Inspections

Inspection records and compliance data for Guilin Pharmaceutical Co., Ltd. in Guilin. 4 FDA inspections on record, 2 Form 483s, last inspected August 18, 2023.

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Company Profile

This profile covers Guilin Pharmaceutical Co., Ltd. based in Guilin, China.

FDA Inspection History

FDA inspections
4
OAI
0
VAI
3
NAI
1
Form 483s
2
Warning letters
0

First inspected September 2, 2011. Last inspected August 18, 2023.

Most cited issue areas

  • Computer control of master formula records1 inspection
  • Equipment Design, Size and Location1 inspection
  • Procedures not in writing, fully followed1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
August 18, 2023NAIHuman Drugs · Drug Quality Assurance1217732
July 19, 2018VAIHuman Drugs · Drug Quality Assurance1061489
March 13, 2015VAIHuman Drugs · Drug Quality Assurance920262
September 2, 2011VAIHuman Drugs · Drug Quality Assurance748950
FDA documents

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

Other regulators (1)
  • China NMPA · 27 inspections · last December 17, 2019
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Formosa Laboratories, Inc.
Kaken Pharmaceutical Co., Ltd.
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Company Information

Name

Guilin Pharmaceutical Co., Ltd.

FEI Number

3002807125

Address

No. 43 Qilidian Road, Guilin, China

Country

China

ID: 8a53776f-b81a-417d-b1c5-ea1cd2d0b0a8

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