FDA Inspection 1333548 — Premium Plastic Solutions Llc
The FDA completed an inspection of Premium Plastic Solutions Llc on Aug 25, 2026 in Latrobe, PA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 25, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Latrobe, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23050 | ISO 13485:2016 Clause 5.2 | Top management did not ensure requirements are determined and met |
| 23155 | ISO 13485:2016 Clause 7.5.1 | Production and service provision not adequate |
| 23240 | ISO 13485:2016 Clause 8.3.2 | Nonconforming product was not dispositioned appropriately |