FDA Inspection
Enviropak LLCEnviropak LLC – FDA Inspection, Jul 11, 2018
Record Details
This FDA Inspection record concerns Enviropak LLC, with an inspection on July 11, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 89704c75-dce6-4a99-9573-409243e6a855
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1058918
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(b)Supplier notification of changes
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Other FDA inspections of Enviropak LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2026 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 24, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Enviropak LLC
- FDA Inspection 1337046 - 2026-09-23
- FDA Inspection 915736 - 2015-02-24
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