FDA Inspection
Metropolis International LLCMetropolis International LLC – FDA Inspection, Aug 6, 2026
Record Details
This FDA Inspection record concerns Metropolis International LLC, with an inspection on August 6, 2026, issued by the New York District Office, covering medical devices & rad health.
- Company
- Metropolis International LLC
- Inspection Date
- August 6, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 80eacae0-7b68-4fec-a5fd-7acc4f718e36
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1330988
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.35(b)Records of servicing activities do not include required information
- ISO 13485:2016 Clause 5.6.1Management review procedures not documented
- ISO 13485:2016 Clause 7.5.4Servicing procedures and reference materials and measurements not documented
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
- ISO 13485:2016 Clause 8.2.4Internal audit procedures not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
- ISO 13485:2016 Clause 8.5.3Preventive action procedures not documented
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Other FDA inspections of Metropolis International LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2023 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| February 28, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 3, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Metropolis International LLC
- FDA Inspection 1195879 - 2023-01-27
- FDA Inspection 1119407 - 2020-02-28
- FDA Inspection 881676 - 2014-06-03
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