576181

Washington Homeopathic Products, Inc. — FEI 3006489197

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 15, 2009
Fiscal Year
2009
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Berkeley Springs, WV (United States)

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
180121 CFR 211.84(a)Components withheld from use pending release
185121 CFR 211.84(e)Rejecting When Specifications Not Met
192821 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability
194221 CFR 211.180(e)Records reviewed annually
200921 CFR 211.188Prepared for each batch, include complete information
202821 CFR 211.192Extent of discrepancy, failure investigations
457621 CFR 211.192No written record of investigation
900121 CFR 211.22(a)Lack of quality control unit