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Intersurgical Medical Apparatus (Changzhou) Co., Ltd., Changzhou, China – FDA Inspections

Inspection records and compliance data for Intersurgical Medical Apparatus (Changzhou) Co., Ltd. in Changzhou. 1 FDA inspection on record, 1 Form 483, last inspected August 28, 2025.

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Company Profile

This profile covers Intersurgical Medical Apparatus (Changzhou) Co., Ltd. based in Changzhou, China.

FDA Inspection History

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

Inspected August 28, 2025.

Most cited issue areas

  • Documentation1 inspection
  • Environmental control Lack of or inadequate procedures1 inspection
  • Lack of or inadequate complaint procedures1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
August 28, 2025VAIMedical Devices & Rad Health · Compliance: Medical Devices1281374
FDA documents

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

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Company Information

Name

Intersurgical Medical Apparatus (Changzhou) Co., Ltd.

FEI Number

3015168843

Address

No. 1011 Liaohe Road, Xuejiazhen Xinbei District, Changzhou, China

Country

China

ID: 13bfbdda-810e-462e-88ad-538c326b1a3d

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