# FDA 483 - Wayne G. Shreffler, M.D. - January 31, 2020

Source: https://www.globalkeysolutions.net/records/483/wayne-g-shreffler-md/7495e4d7-100a-4d2f-affe-9b8cf78c1817

> FDA 483 for Wayne G. Shreffler, M.D. on January 31, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wayne G. Shreffler, M.D.
- Inspection Date: 2020-01-31
- Product Type: other
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Wayne G. Shreffler, M.D. in Boston, MA, a clinical investigator, revealed one observation related to the conduct of a clinical investigation. The firm failed to conduct an investigation in accordance with the investigational plan, specifically regarding the allocation of study materials to subjects. This indicates a deviation from established study protocols and training materials.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)

Company: https://www.globalkeysolutions.net/companies/wayne-g-shreffler-md/1b1fb4b1-eb9d-4ce8-822c-042786db6533

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7