# FDA 483 - Joseph M.B. Croffie, MD - March 16, 2018

Source: https://www.keypedia.com/records/483/joseph-mb-croffie-md/0d1b0f52-dfb6-47d2-8fee-2cf7f2b738a1

> FDA 483 for Joseph M.B. Croffie, MD on March 16, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Joseph M.B. Croffie, MD
- Inspection Date: 2018-03-16
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Joseph M.B. Croffie, M.D., a clinical investigator in Indianapolis, IN, revealed significant deficiencies in the conduct of an investigation. Observations included failures to adhere to the investigational plan, specifically regarding documentation of subject inclusion/exclusion criteria and proper reporting of adverse events. Additionally, the firm was cited for inadequate and inaccurate case histories, with notable discrepancies in investigational drug disposition records.

## Related Officers

- [ Director, Bioresearch Monitoring Division (West) and FDA Delegate to the OECD Working Party on GLPs](https://www.keypedia.com/people/eric-s-pittman/878b3087-615d-4e1f-9a9f-0649b46b817b)
- [U.S. Food and Drug Administration](https://www.keypedia.com/people/myra-k-casey/a2fae714-2ba3-4c60-9f54-990fc7b169c9)

Company: https://www.keypedia.com/companies/joseph-mb-croffie-md/68f885c1-e648-4e33-8e31-9600957b9e65

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