FDA Inspection 1330988 — Metropolis International LLC
The FDA completed an inspection of Metropolis International LLC on Aug 6, 2026 in Long Island City, 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
- Aug 6, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Long Island City, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23060 | ISO 13485:2016 Clause 5.6.1 | Management review procedures not documented |
| 23162 | ISO 13485:2016 Clause 7.5.4 | Servicing procedures and reference materials and measurements not documented |
| 23215 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures lack required elements |
| 23221 | ISO 13485:2016 Clause 8.2.4 | Internal audit procedures not documented |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |
| 23261 | ISO 13485:2016 Clause 8.5.3 | Preventive action procedures not documented |
| 23266 | 21 CFR 820.35(b) | Records of servicing activities do not include required information |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |