# FDA 483 - Dr. Norman R. Wasel - April 11, 2014

Source: https://www.keypedia.com/records/483/dr-norman-r-wasel/49e79758-a947-407f-b5d7-2a9cf9c07a25

> FDA 483 for Dr. Norman R. Wasel on April 11, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Norman R. Wasel
- Inspection Date: 2014-04-11
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Dr. Norman R. Wasel, a clinical investigator in Edmonton, Alberta, revealed significant deficiencies in clinical study conduct. Observations included a failure to maintain adequate case histories with proper verification of electronic source data and a failure to obtain informed consent from human subjects in accordance with regulations, specifically regarding a revised consent document for study CC-1004-PSOR-009.

## Related Officers

- [Colleen Aspinwall](https://www.keypedia.com/people/colleen-aspinwall/d3c98644-e796-4a7f-82d0-9c49e93c0940)

Company: https://www.keypedia.com/companies/dr-norman-r-wasel/0a1077c2-e588-4641-ab45-09f77994fc2a

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4