FDA Inspection
Kanec Usa, Inc.Kanec Usa, Inc. – FDA Inspection, Apr 19, 2010
Record Details
This FDA Inspection record concerns Kanec Usa, Inc., with an inspection on April 19, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Kanec Usa, Inc.
- Inspection Date
- April 19, 2010
- Product Type
- Drugs
View Company Profile
ID · a310052c-564c-43ed-83b2-1af5b91bd049
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 655743
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
12- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 110.80(a)(1)Storage
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.20(b)(3)(i)Management representative implementing the quality system
Showing 10 of 12 citations.
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.