FDA Inspection 545834 — GCP Laboratories

GCP Laboratories — FEI 1019058

The FDA completed an inspection of GCP Laboratories on November 6, 2008 in Gulfport, MS. 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
November 6, 2008
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gulfport, MS (United States)

Citations

IDCFRDescription
194321 CFR 211.180(e)(1)Review of representative number of batches
979221 CFR 106.30(b)(3)Stability analysis