FDA Inspection
Axcentria Pharmaceuticals LLCAxcentria Pharmaceuticals LLC – FDA Inspection, Aug 31, 2011
Record Details
This FDA Inspection record concerns Axcentria Pharmaceuticals LLC, with an inspection on August 31, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 31, 2011
- Product Type
- Drugs
View Company Profile
ID · 8afab0f3-830c-40c9-85bf-a5e866885c68
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 741857
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.134(b)Representative samples after completion
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Axcentria Pharmaceuticals LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 25, 2014 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 14, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Axcentria Pharmaceuticals LLC
- FDA Inspection 905248 - 2014-11-25
- FDA Inspection 872664 - 2014-04-14
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.