# FDA 483 - Ace Products & Consulting LLC - April 04, 2024

Source: https://www.keypedia.com/records/483/ace-products-consulting-llc/d7cda1d9-9393-4d9e-bc7a-071aade930b9

> FDA 483 for Ace Products & Consulting LLC on April 04, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ace Products & Consulting LLC
- Inspection Date: 2024-04-04
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Ace Products & Consulting LLC, a contract testing lab in Ravenna, OH, revealed significant deficiencies in quality control and data integrity. The firm failed to properly investigate out-of-specification results and retested samples without scientific justification. Additionally, the inspection found inadequate controls over computer systems, including a lack of user permissions, audit trails, and individual logins for GC-MS software, alongside missing or unfollowed written procedures for investigations and data review.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)

Company: https://www.keypedia.com/companies/ace-products-consulting-llc/6c585ef3-bc0a-4e47-8947-7e74b4160ae3

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