# FDA 483 - Med-Mizer, Inc. - August 06, 2021

Source: https://www.globalkeysolutions.net/records/483/med-mizer-inc/7b14695e-9500-40bd-be73-e1dca845c0be

> FDA 483 for Med-Mizer, Inc. on August 06, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Med-Mizer, Inc.
- Inspection Date: 2021-08-06
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Med-Mizer, Inc. in Batesville, IN, a manufacturer of hospital beds and therapy chairs, was cited with eight observations during an FDA inspection. The firm's quality system is significantly deficient, with multiple repeat observations indicating systemic failures in design control, in-process product control, rework procedures, purchasing controls, equipment calibration, sampling methods, and device history records. These issues suggest a lack of adequate procedures and consistent adherence to established quality system requirements for medical device manufacturing.

## Related Documents

- [WARNING_LETTER - 2014-03-07](https://www.globalkeysolutions.net/records/warning_letter/med-mizer-inc/5c073484-385e-4160-90c4-8c04eae59634)

## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/joseph-r-strelnik/1fb7d50e-abf2-45ef-85a8-71c61b33e42d)

Company: https://www.globalkeysolutions.net/companies/med-mizer-inc/c0b6af4d-62cd-4e88-ab20-60b01d9a5e45

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0