683308

Green Pharmaceuticals, Inc. — FEI 3004079658

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 15, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Camarillo, CA (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
155021 CFR 211.125(f)Procedures Written and Followed
172521 CFR 211.134(c)Examinations documented
177421 CFR 211.142(a)Quarantine - actual practice
194221 CFR 211.180(e)Records reviewed annually
200421 CFR 211.184(d)Labeling: documentation of exam and review
202021 CFR 211.188(b)(8)Labeling Control Records and Label Copies
202621 CFR 211.192Quality control unit review of records
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
435921 CFR 211.170(b)(1)Retention time of reserve samples, in general