FDA Inspection
Rachael A. Callcut, M.D., M.S.P.H.Rachael A. Callcut, M.D., M.S.P.H. – FDA Inspection, Dec 13, 2018
Record Details
This FDA Inspection record concerns Rachael A. Callcut, M.D., M.S.P.H., with an inspection on December 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 7dd4a5df-f6bb-4542-b19b-277db4fa4122
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1075337
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 50.20Consent not obtained, exceptions do not apply
- 21 CFR 50.25(a)(8)Participation; refusal and discontinuance
- 21 CFR 50.25(a)(5)Confidentiality, FDA inspection of records
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.