FDA Inspection
Axium Healthcare Pharmacy dba Balanced Solutions CompoundingAxium Healthcare Pharmacy dba Balanced Solutions Compounding – FDA Inspection, Mar 15, 2013
Record Details
This FDA Inspection record concerns Axium Healthcare Pharmacy dba Balanced Solutions Compounding, with an inspection on March 15, 2013, issued by the Center for Veterinary Medicine, covering veterinary.
- Inspection Date
- March 15, 2013
- Product Type
- Veterinary
View Company Profile
ID · d5a98e20-c0cf-4841-bf9b-3bc792f67437
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 823282
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
9- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.42(c)(1)Incoming material area
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.