# FDA 483 - James E. Cain, M.D. - August 27, 2021

Source: https://www.globalkeysolutions.net/records/483/james-e-cain-md/39a0759c-031c-49a5-9d3c-69b54f11ec21

> FDA 483 for James E. Cain, M.D. on August 27, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: James E. Cain, M.D.
- Inspection Date: 2021-08-27
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: FMC Science, LLC, a clinical investigator in Lampasas, TX, was inspected by the FDA. The inspection revealed that an investigation was not conducted in accordance with the signed statement of investigator and investigational plan. Specifically, a subject who met the criteria for discontinuation due to a decrease in bone mineral density was not removed from study drug dosing as required by the protocol.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/michelle-j-hines/c8087e41-6b8a-4b9a-92ad-bba500ce6fee)

Company: https://www.globalkeysolutions.net/companies/james-e-cain-md/1a3817f4-6107-4ff7-b317-3a4c219e1987

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab