FDA Inspection
Enviropak LLCEnviropak LLC – FDA Inspection, Sep 23, 2026
Record Details
This FDA Inspection record concerns Enviropak LLC, with an inspection on September 23, 2026, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Enviropak LLC
- Inspection Date
- September 23, 2026
- Product Type
- Devices
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ID · 9b09b64a-6ab0-4146-b255-2aecd18c4440
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1337046
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- ISO 13485:2016 Clause 8.5.1Management review records not maintained
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
- ISO 13485:2016 Clause 8.2.4Internal audit criteria, scope, interval, and methods not defined and recorded
- ISO 13485:2016 Clause 6.3Requirements for infrastructure maintenance activities not documented
- ISO 13485:2016 Clause 8.5.1Production controls not adequate
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Other FDA inspections of Enviropak LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 24, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Enviropak LLC
- FDA Inspection 1058918 - 2018-07-11
- FDA Inspection 915736 - 2015-02-24
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