FDA Inspection
Axcentria Pharmaceuticals LLCAxcentria Pharmaceuticals LLC – FDA Inspection, Apr 14, 2014
Record Details
This FDA Inspection record concerns Axcentria Pharmaceuticals LLC, with an inspection on April 14, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 14, 2014
- Product Type
- Drugs
View Company Profile
ID · 25bd9e24-be1c-42a8-88c2-490f144b66ce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 872664
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.194(a)(5)Calculations performed are in the records
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.186(b)(7)Theoretical Yield and Percentages
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
Showing 10 of 11 citations.
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 |
| August 31, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Axcentria Pharmaceuticals LLC
- FDA Inspection 905248 - 2014-11-25
- FDA Inspection 741857 - 2011-08-31
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.