FDA Inspection
Malem MedicalMalem Medical – FDA Inspection, Feb 14, 2018
Record Details
This FDA Inspection record concerns Malem Medical, with an inspection on February 14, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 96107fdd-4965-4417-aabd-c9a0c2302f2b
Inspection Facts
- Inspection number
- 1044236
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.22Quality audits - auditor independence
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