FDA Inspection 727918 — Sciarra Laboratories, Inc.

Sciarra Laboratories, Inc. — FEI 1000306996

The FDA completed an inspection of Sciarra Laboratories, Inc. on June 3, 2011 in Hicksville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 3, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hicksville, NY (United States)

Citations

IDCFRDescription
139521 CFR 211.103Actual vs. theoretical yields not determined
202721 CFR 211.192Investigations of discrepancies, failures