# FDA 483 - Capstone Surgical Technologies LLC - April 02, 2019

Source: https://www.keypedia.com/records/483/capstone-surgical-technologies-llc/e509a8ca-4906-4787-a5d0-6e41aa95bff1

> FDA 483 for Capstone Surgical Technologies LLC on April 02, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Capstone Surgical Technologies LLC
- Inspection Date: 2019-04-02
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Capstone Surgical Technologies LLC, a medical device establishment in Troy, MI, was inspected by the FDA. The inspection revealed deficiencies in the firm's quality audit procedures, including issues with auditor qualifications, audit closure verification, and incomplete audit records. These findings indicate a lack of adequate control over their internal quality audit system.

## Related Officers

- [David J. Gasparovich](https://www.keypedia.com/people/david-j-gasparovich/478888db-d4b3-481a-89f5-ee234a160f07)

Company: https://www.keypedia.com/companies/capstone-surgical-technologies-llc/ba9c636b-2efc-48f7-a993-93d6dfb82e9c

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