FDA Inspection
ISLAND DENTAL LAB DBA EMERALD DENTAL LABISLAND DENTAL LAB DBA EMERALD DENTAL LAB – FDA Inspection, Mar 11, 2025
Record Details
This FDA Inspection record concerns ISLAND DENTAL LAB DBA EMERALD DENTAL LAB, with an inspection on March 11, 2025, issued by the New York District Office, covering medical devices & rad health.
- Inspection Date
- March 11, 2025
- Product Type
- Medical Devices & Rad Health
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ID · ecdaf409-3e2f-4052-a4b5-030c0333338d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1263525
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
5- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 830.310(b)GUDID Information required for unique device identification.
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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