# FDA 483 - Bemis Manufacturing Co. - August 14, 2019

Source: https://www.keypedia.com/records/483/bemis-manufacturing-co/1dd61197-4d9f-44c7-a239-7473136283c2

> FDA 483 for Bemis Manufacturing Co. on August 14, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bemis Manufacturing Co.
- Inspection Date: 2019-08-14
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Bemis Manufacturing Co. in Sheboygan Falls, WI, a medical device manufacturer, revealed two significant observations. The firm failed to adequately establish procedures for design input, specifically omitting a critical use scenario for their Quick-Fit Suction Liner System. Additionally, their risk analysis was found to be inadequate due to a lack of defined severity for potential injuries from device failures.

## Related Officers

- [Nicholas Z. Lu](https://www.keypedia.com/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)

Company: https://www.keypedia.com/companies/bemis-manufacturing-co/4730d9b9-dc78-4897-ba54-82711a13c477

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d