FDA Inspection
Ideavillage Products Corp.Ideavillage Products Corp. – FDA Inspection, Sep 20, 2024
Record Details
This FDA Inspection record concerns Ideavillage Products Corp., with an inspection on September 20, 2024, issued by the New Jersey District Office, covering medical devices & rad health.
- Company
- Ideavillage Products Corp.
- Inspection Date
- September 20, 2024
- Product Type
- Medical Devices & Rad Health
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ID · 8d8f60c1-c7a3-4e34-a6b9-2451a3f1cd9a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1249662
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 803.17Lack of Written MDR Procedures
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