# FDA 483 - SPR Therapeutics Inc. - February 22, 2018

Source: https://www.globalkeysolutions.net/records/483/spr-therapeutics-inc/3408b0c1-2e52-4e9d-8d6e-e1fba7bfc1c5

> FDA 483 for SPR Therapeutics Inc. on February 22, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SPR Therapeutics Inc.
- Inspection Date: 2018-02-22
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of SPR Therapeutics Inc., a medical device manufacturer in Cleveland, OH, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for handling customer complaints, including documentation of investigations and supplier corrective actions. Additionally, procedures for qualifying and monitoring suppliers were found to be insufficient, lacking clear guidelines for evaluating pre-audit questionnaires and defining triggers for further action.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/laureen-m-geniusz/759a858e-e3f3-4c48-8194-9804c7ab2a7b)

Company: https://www.globalkeysolutions.net/companies/spr-therapeutics-inc/aafd248d-b650-4e97-b6af-32d261d6e060

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