FDA Inspection
Eurolatex Sdn.Bhd.Eurolatex Sdn.Bhd. – FDA Inspection, Nov 30, 2023
Record Details
This FDA Inspection record concerns Eurolatex Sdn.Bhd., with an inspection on November 30, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bfebd843-f05b-4677-a1bb-b2cee381059c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1224945
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR - not or inadequately maintained
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