576188

Washington Homeopathic Products, Inc. — FEI 3006489197

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 15, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Berkeley Springs, WV (United States)

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
136121 CFR 211.100(a)Absence of Written Procedures
180121 CFR 211.84(a)Components withheld from use pending release
192821 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability
204421 CFR 211.196Distribution Record Requirements
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
430721 CFR 211.80(d)Status of Each Lot Identified
436421 CFR 211.176Failing to test for penicillin cross-contamination
437121 CFR 211.188(b)(9)Description of containers and closures
900121 CFR 211.22(a)Lack of quality control unit