FDA Inspection
Omthera PharmaceuticalsOmthera Pharmaceuticals – FDA Inspection, Nov 5, 2013
Record Details
This FDA Inspection record concerns Omthera Pharmaceuticals, with an inspection on November 5, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Omthera Pharmaceuticals
- Inspection Date
- November 5, 2013
- Product Type
- Drugs
View Company Profile
ID · 5b52c42c-f2b7-4fb7-8cbe-d612b2b897c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 857298
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 312.50General responsibilities of sponsors
- 21 CFR 312.57(a)Records of receipt, shipment, disposition
- 21 CFR 312.53(b)Shipment to unauthorized persons
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.