FDA Inspection
DAWA MEDICAL LLCDAWA MEDICAL LLC – FDA Inspection, May 7, 2026
Record Details
This FDA Inspection record concerns DAWA MEDICAL LLC, with an inspection on May 7, 2026, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.
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ID · 6026cd8a-50d8-42d7-be0b-bd6c36d3944c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1315868
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 4.1.1QMS not documented and maintained adequately
- 21 CFR 803Lack of Written MDR Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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