FDA Inspection
SUTUMED CORPORATIONSUTUMED CORPORATION – FDA Inspection, Mar 8, 2019
Record Details
This FDA Inspection record concerns SUTUMED CORPORATION, with an inspection on March 8, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5ad0a5c6-294e-40b8-bd18-7774bbc0f1f8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1084278
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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