# FDA 483 - Miami University - November 05, 2021

Source: https://www.globalkeysolutions.net/records/483/miami-university/65caa267-4861-4f17-aacc-6a2c3cbb43c8

> FDA 483 for Miami University on November 05, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Miami University
- Inspection Date: 2021-11-05
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: This FDA Form 483 details significant deficiencies at Miami University's control testing laboratory in Oxford, OH, following an inspection from November 1-5, 2021. The firm was cited for a complete lack of a Quality Control Unit and written procedures, severe data integrity issues including manipulation of test results, inadequate training, and uncalibrated equipment. These observations indicate a fundamental breakdown in GMP compliance for API Heparin Sodium, USP testing.

## Related Officers

- [Consumer Safety Officer , Investigator](https://www.globalkeysolutions.net/people/lisa-r-hilliard/611735cf-5c20-424c-801a-03888d8d1b0a)
- [Drug Specialist](https://www.globalkeysolutions.net/people/lauren-n-howard/538f77fe-b977-49c9-a5b3-289cf8a6e886)

Company: https://www.globalkeysolutions.net/companies/miami-university/dc0f3627-13b5-4aa9-a2b7-d63aea38b221

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