# FDA 483 - Computer Programs & Systems Inc - September 13, 2023

Source: https://www.keypedia.com/records/483/computer-programs-systems-inc/d0c2302d-6cd0-43ad-8f42-4c2e53095938

> FDA 483 for Computer Programs & Systems Inc on September 13, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Computer Programs & Systems Inc
- Inspection Date: 2023-09-13
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Computer Programs & Systems Inc. in Mobile, AL, a medical device manufacturer, identified three significant quality system deficiencies. The firm failed to establish adequate procedures for design control and statistical techniques for its Blood Establishment Computer Software. Additionally, the company did not properly document corrective and preventive actions related to programming changes and software updates.

## Related Officers

- [Cody D. Rickman](https://www.keypedia.com/people/cody-d-rickman/54deec25-dc65-4402-991a-ad5589bad78b)

Company: https://www.keypedia.com/companies/computer-programs-systems-inc/1577bbe7-e765-4c3c-84af-668d8f8d3746

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea