# FDA 483 - Pharmalogic Cincinnati, LLC - December 08, 2023

Source: https://www.keypedia.com/records/483/pharmalogic-cincinnati-llc/40c1172a-a4e1-42c1-b66c-2b36a14953bd

> FDA 483 for Pharmalogic Cincinnati, LLC on December 08, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Pharmalogic Cincinnati, LLC
- Inspection Date: 2023-12-08
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Pharmalogic Cincinnati, LLC, a PET manufacturer, was inspected by the FDA. The inspection revealed a significant deficiency in their quality system, specifically regarding master production and control records. The firm's master batch records lacked complete production and control instructions, including critical process parameters for mixing.

## Related Officers

- [Consumer Safety Officer , Investigator](https://www.keypedia.com/people/lisa-r-hilliard/611735cf-5c20-424c-801a-03888d8d1b0a)
- [Mathematical statistician](https://www.keypedia.com/people/wen-ning-chan/e1f71810-6994-4474-876f-699ea9dee32c)

Company: https://www.keypedia.com/companies/pharmalogic-cincinnati-llc/6173ca4e-ce05-4c75-8c28-d2b45103ab6d

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