FDA Inspection 1315104 — Emerald Supply Inc
The FDA completed an inspection of Emerald Supply Inc on Apr 16, 2026 in Brooklyn, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 16, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Brooklyn, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 23032 | ISO 13485:2016 Clause 4.2.1 | Quality management system documentation not adequate |
| 23049 | ISO 13485:2016 Clause 5.1 | Lack of evidence for top management's commitment to QMS |
| 23088 | ISO 13485:2016 Clause 7.1 | Records of risk management activities in product realization not maintained |
| 23263 | 21 CFR 820.35(a) | Records for complaints involving failure to meet specifications not maintained |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |