# FDA 483 - Keystone Manufacturing LLC. - December 11, 2019

Source: https://www.keypedia.com/records/483/keystone-manufacturing-llc/2ef01e03-0dfa-4c70-a31b-8af123d629ad

> FDA 483 for Keystone Manufacturing LLC. on December 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Keystone Manufacturing LLC.
- Inspection Date: 2019-12-11
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Keystone Manufacturing LLC. in Kalamazoo, MI, a medical device manufacturer, revealed five observations related to significant deficiencies in their quality system. The firm failed to adequately establish procedures for quality audits, corrective and preventive actions, nonconforming product control, and supplier controls. Notably, two observations were repeats from a previous inspection, highlighting persistent issues.

## Related Officers

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

Company: https://www.keypedia.com/companies/keystone-manufacturing-llc/7ea1e876-c62d-4547-a081-97d9ec12d7ba

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