# FDA 483 - Checkpoint Surgical Inc - March 15, 2018

Source: https://www.keypedia.com/records/483/checkpoint-surgical-inc/a1444be1-3ef2-41be-a039-9ab089048dc0

> FDA 483 for Checkpoint Surgical Inc on March 15, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Checkpoint Surgical Inc
- Inspection Date: 2018-03-15
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Checkpoint Surgical Inc, a medical device manufacturer in Cleveland, OH, was cited for inadequate quality system procedures during an FDA inspection. Observations included deficiencies in complaint handling, acceptance activities, corrective and preventive actions, and process control procedures. These issues indicate a lack of robust controls over manufacturing processes and quality documentation.

## Related Documents

- [EIR - 2018-03-15](https://www.keypedia.com/records/eir/checkpoint-surgical-inc/2dc8c2cd-227d-49b0-956f-403b8a831a31)

## Related Officers

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

Company: https://www.keypedia.com/companies/checkpoint-surgical-inc/a261a054-24ab-4560-8464-3aa15259c887

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