917528

LNK International, Inc. — FEI 2432212

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 30, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hauppauge, NY (United States)

Citations

IDCFRDescription
200921 CFR 211.188Prepared for each batch, include complete information
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
357321 CFR 211.101(b)Measured components for manufacturing
358521 CFR 211.110(a)Control procedures to monitor and validate performance
430321 CFR 211.67(b)Written procedures fail to include