884504

The Lighthouse for the Blind — FEI 1000118065

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 30, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Saint Louis, MO (United States)

Citations

IDCFRDescription
113321 CFR 211.25(a)GMP Training Frequency
113421 CFR 211.25(b)Supervisor Training/Education/Experience
145021 CFR 211.113(a)Procedures for non-sterile drug products
176721 CFR 211.137(a)Expiration date lacking
185221 CFR 211.94(a)Reactive/Additive/Absorptive Containers/Closures
192621 CFR 211.166(b)Adequate number of batches on stability
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures