# FDA 483 - Aspen Surgical Products, Inc. - November 08, 2017

Source: https://www.globalkeysolutions.net/records/483/aspen-surgical-products-inc/c894591e-9199-41de-b89d-f3257b9765fa

> FDA 483 for Aspen Surgical Products, Inc. on November 08, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aspen Surgical Products, Inc.
- Inspection Date: 2017-11-08
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Aspen Surgical Products, Inc. in Caledonia, MI, received a Form FDA 483 with five observations related to its quality system for medical devices. The inspection revealed deficiencies in procedures for corrective and preventive actions, control of nonconforming product, design validation, and monitoring of validated process parameters. Additionally, the firm failed to document in-process inspection results.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sargum-c-sood/980cd904-0fac-488d-8ea9-39a44d8ea21d)

Company: https://www.globalkeysolutions.net/companies/aspen-surgical-products-inc/fff21709-664d-4d56-86a9-bd998aec52f9

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