FDA Inspection
ANIP Aquisition CompanyANIP Aquisition Company – FDA Inspection, Jun 19, 2009
Record Details
This FDA Inspection record concerns ANIP Aquisition Company, with an inspection on June 19, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ANIP Aquisition Company
- Inspection Date
- June 19, 2009
- Product Type
- Drugs
View Company Profile
ID · d04de340-617a-4cf8-a0be-8c3872a7b2dc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 590065
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
- 21 CFR 314.80(c)(2)Interval
- 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.