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

Source: https://www.keypedia.com/records/483/bemis-manufacturing-co/1191671e-0c42-45ff-baef-44a5c3e566ba

> 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's procedures for design input were found to be inadequately established, specifically regarding a use scenario for the Quick-Fit Suction Liner System. Additionally, the firm's risk analysis was deemed inadequate due to insufficient definition of severity for potential injuries from medical 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/8d51c620-9bce-4684-906b-187afa1d8d6e

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