FDA Inspection 1337046 — Enviropak, LLC
The FDA completed an inspection of Enviropak, LLC on Sep 23, 2026 in Peachtree City, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 23, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Peachtree City, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23063 | ISO 13485:2016 Clause 5.6.1 | Management review records not maintained |
| 23077 | ISO 13485:2016 Clause 6.3 | Requirements for infrastructure maintenance activities not documented |
| 23156 | ISO 13485:2016 Clause 7.5.1 | Production controls not adequate |
| 23215 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures lack required elements |
| 23223 | ISO 13485:2016 Clause 8.2.4 | Internal audit criteria, scope, interval, and methods not defined and recorded |