FDA Inspection
JKM INTERNATIONAL, INC.JKM INTERNATIONAL, INC. – FDA Inspection, May 23, 2019
Record Details
This FDA Inspection record concerns JKM INTERNATIONAL, INC., with an inspection on May 23, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · f72c4820-6580-4516-9d45-04fea318e928
Inspection Facts
- Inspection number
- 1092657
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of JKM INTERNATIONAL, INC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for JKM INTERNATIONAL, INC.
- FDA Inspection 1242542 - 2024-06-06
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