FDA Inspection
Incumedx LLCIncumedx LLC – FDA Inspection, Sep 12, 2014
Record Details
This FDA Inspection record concerns Incumedx LLC, with an inspection on September 12, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Incumedx LLC
- Inspection Date
- September 12, 2014
- Product Type
- Devices
View Company Profile
ID · 49652296-c6cd-4091-8964-b6707fed39a7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 896798
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 58.10Notifying contractor of GLP status
- 21 CFR 58.185(b)Final report: not signed by study director
- 21 CFR 58.120(a)(6)Protocol: experimental design
- 21 CFR 58.120(a)(11)Protocol: date and signature
- 21 CFR 58.120(a)(3)Protocol: sponsor name and address
- 21 CFR 58.190(a)Archives: data, documentation, specimens
- 21 CFR 58.185(a)(6)Final report: description of methods
- 21 CFR 58.185(a)(1)Final report: name, address, dates
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.