FDA Inspection
Jung Rim Medical Industrial Co., LtdJung Rim Medical Industrial Co., Ltd – FDA Inspection, Jan 25, 2024
Record Details
This FDA Inspection record concerns Jung Rim Medical Industrial Co., Ltd, with an inspection on January 25, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- January 25, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · f00ddacd-7659-47cb-83ff-b605500cca35
Inspection Facts
- Inspection number
- 1227683
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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