FDA Inspection
Premium Plastic Solutions LlcPremium Plastic Solutions Llc – FDA Inspection, Aug 25, 2026
Record Details
This FDA Inspection record concerns Premium Plastic Solutions Llc, with an inspection on August 25, 2026, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 25, 2026
- Product Type
- Devices
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ID · c1799b70-923e-4619-8db2-99f43ea6216b
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1333548
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- ISO 13485:2016 Clause 8.5.2Nonconforming product was not dispositioned appropriately
- ISO 13485:2016 Clause 5.2Top management did not ensure requirements are determined and met
- ISO 13485:2016 Clause 7.5.1Production and service provision not adequate
- ISO 13485:2016 Clause 4.1.3Risk-based approach not applied to QMS processes
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Other FDA inspections of Premium Plastic Solutions Llc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 30, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Premium Plastic Solutions Llc
- FDA Inspection 1077571 - 2018-12-11
- FDA Inspection 944026 - 2015-09-30
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