# FDA 483 - APS Materials, Inc. - January 30, 2020

Source: https://www.globalkeysolutions.net/records/483/aps-materials-inc/50b3f4d3-1d34-4a30-9ea9-dc81fb3208c7

> FDA 483 for APS Materials, Inc. on January 30, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: APS Materials, Inc.
- Inspection Date: 2020-01-30
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: APS Materials, Inc., a medical device manufacturer in Dayton, OH, was inspected by the FDA from January 28-30, 2020. The inspection revealed deficiencies in the firm's complaint handling system, specifically regarding the maintenance of complaint files and the completeness of complaint investigation records. These issues indicate a lack of adequate procedures for evaluating Medical Device Reporting requirements and documenting essential investigation details.

## Related Documents

- [483 - 2023-03-15](https://www.globalkeysolutions.net/records/483/aps-materials-inc/25509084-e3f8-4311-87c3-8e8bc2a56544)

## Related Officers

- [Shannon A. Gregory](https://www.globalkeysolutions.net/people/shannon-a-gregory/3e791321-dced-4e1d-89a1-3da91d577961)

Company: https://www.globalkeysolutions.net/companies/aps-materials-inc/ee5ee738-bae9-4108-b367-f06a55301f5d

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22