# FDA 483 - Centurion Medical Products, LP - August 20, 2019

Source: https://www.keypedia.com/records/483/centurion-medical-products-lp/e5fcdcbb-a59f-440d-8cfa-95e8db18ad51

> FDA 483 for Centurion Medical Products, LP on August 20, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Centurion Medical Products, LP
- Inspection Date: 2019-08-20
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Centurion Medical Products Corporation, a medical device manufacturer in Howell, MI, was cited for multiple quality system deficiencies during an FDA inspection. Observations included inadequate environmental controls, insufficient validation of sterile kit sealing processes and production software, and poorly established procedures for package seal acceptance and corrective and preventive actions. These issues indicate a moderate level of non-compliance with quality system regulations.

## Related Officers

- [Medical Device Senior Operations Officer at FDA](https://www.keypedia.com/people/thomas-a-peter/48a36892-cc03-42bb-8960-978d18f2147a)

Company: https://www.keypedia.com/companies/centurion-medical-products-lp/794d4169-736b-4266-b6d2-e5b942fb1422

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