FDA Inspection
Identi Pharmaceuticals, LLCIdenti Pharmaceuticals, LLC – FDA Inspection, Mar 27, 2017
Record Details
This FDA Inspection record concerns Identi Pharmaceuticals, LLC, with an inspection on March 27, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 970b9dc4-bfe3-4e29-a889-5e2dfe205ef1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007044
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
- 21 CFR 314.80(b)Failure to develop written procedures
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.