FDA Inspection
Bemis Manufacturing Co.Bemis Manufacturing Co. – FDA Inspection, Aug 14, 2019
Record Details
This FDA Inspection record concerns Bemis Manufacturing Co., with an inspection on August 14, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8794a680-2d80-46c9-9fd1-551d15d4148b
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1099553
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bemis Manufacturing Co.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 30, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 4, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bemis Manufacturing Co.
- FDA Inspection 1269501 - 2025-04-30
- FDA Inspection 748330 - 2011-10-04
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