FDA Inspection
Emerald Supply IncEmerald Supply Inc – FDA Inspection, Apr 16, 2026
Record Details
This FDA Inspection record concerns Emerald Supply Inc, with an inspection on April 16, 2026, issued by the New York District Office, covering medical devices & rad health.
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ID · e6f07067-95e1-4034-8c29-bf9959f8de19
Inspection Facts
- Inspection number
- 1315104
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.35(a)Records for complaints involving failure to meet specifications not maintained
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- ISO 13485:2016 Clause 4.2.1Quality management system documentation not adequate
- ISO 13485:2016 Clause 5.1Lack of evidence for top management's commitment to QMS
- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
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