# FDA 483 - Christopher J. Hartnick, MD - June 28, 2019

Source: https://www.keypedia.com/records/483/christopher-j-hartnick-md/07b9f244-d624-4ef7-8bad-606c9ace9780

> FDA 483 for Christopher J. Hartnick, MD on June 28, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Christopher J. Hartnick, MD
- Inspection Date: 2019-06-28
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Christopher J. Hartnick, MD, a sponsor-investigator in Boston, MA, revealed significant deficiencies in the conduct and oversight of an investigational device study. The firm failed to ensure proper monitoring, maintain accurate and complete subject case histories, and secure essential commitments in clinical trial agreements. Additionally, issues were noted with investigational device record-keeping and labeling.

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Company: https://www.keypedia.com/companies/christopher-j-hartnick-md/162c1295-9499-4404-86e9-d8cbb0309d56

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94