# FDA 483 - Penner Mfg Inc - February 11, 2025

Source: https://www.keypedia.com/records/483/penner-mfg-inc/112f8bca-f5fc-4634-962e-4c1836cff257

> FDA 483 for Penner Mfg Inc on February 11, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Penner Mfg Inc
- Inspection Date: 2025-02-11
- Product Type: device
- Office Name: Kansas City District Office
- Summary: Penner Patient Care, Inc. in Aurora, NE, was cited for significant quality system deficiencies during an FDA inspection related to their Class II Hydro-Massage Bath. Observations included a failure to apply unique device identifiers to product labels and a lack of established procedures for corrective and preventive actions. The firm also failed to ensure timely submission of medical device reports and did not establish requirements for suppliers.

## Related Officers

- [Eric C. Fox](https://www.keypedia.com/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.keypedia.com/companies/penner-mfg-inc/2afdfe9c-eced-41f6-9d95-24504a626315

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79