FDA Inspection
Christopher J. Hartnick, MDChristopher J. Hartnick, MD – FDA Inspection, Jun 28, 2019
Record Details
This FDA Inspection record concerns Christopher J. Hartnick, MD, with an inspection on June 28, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 83c1ae76-6ac5-4650-a197-a28b805ac60d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1094514
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 812.43(c)(4)(i)No investigation agreement statement of commitment
- 21 CFR 812.43(c)(4)(iii)No informed consent statement in investigator agreement
- 21 CFR 812.43(c)(4)(ii)No supervision commitment in investigator agreement
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.43(d)Monitors not qualified
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(b)(2)Sponsor device shipment records inadequate
- 21 CFR 812.5(a)Label does not contain required information
- 21 CFR 812.25(e)Sponsor"s lack of written monitoring procedures
- 21 CFR 812.140(a)(3)Investigator's subject records inadequate
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Other FDA inspections of Christopher J. Hartnick, MD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2023 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Christopher J. Hartnick, MD
- FDA Inspection 1221764 - 2023-10-27
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