# FDA 483 - APDM Wearable Technologies, Inc. - March 10, 2022

Source: https://www.keypedia.com/records/483/apdm-wearable-technologies-inc/9fb67ab7-a15f-423a-abec-9dc12f7ee3f4

> FDA 483 for APDM Wearable Technologies, Inc. on March 10, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: APDM Wearable Technologies, Inc.
- Inspection Date: 2022-03-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of APDM Wearable Technologies, Inc. in Portland, OR, identified one observation concerning the inadequate implementation of equipment maintenance procedures. The firm failed to properly document preventative maintenance activities for its equipment, as required by its internal procedures. This indicates a lapse in adherence to established quality system requirements.

## Related Officers

- [investigator](https://www.keypedia.com/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

Company: https://www.keypedia.com/companies/apdm-wearable-technologies-inc/fec0f43c-abc7-4e82-85f7-79e45aa12f00

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822