Company
Korea (the Republic of)IntroMedic Co., Ltd., Anyang, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for IntroMedic Co., Ltd. in Anyang. 1 FDA inspection on record, 1 Form 483, last inspected July 06, 2017.
Company Profile
This profile covers IntroMedic Co., Ltd. based in Anyang, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected July 6, 2017.
Most cited issue areas
- Incorrect translation to production specifications1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 6, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1019052 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
IntroMedic Co., Ltd.
FEI Number
3013489112
Address
F-Rtek 6 Floor, 11-25 Simin-Daero 327 Beon-Gil; Dongan District, Anyang, Korea (the Republic of)
Country
Korea (the Republic of)
ID: f84ce2c1-d2b9-4724-80ca-0d30127d20f4