FDA Inspection 1233712 — Strides Alathur Private Limited

Strides Alathur Private Limited — FEI 3005151016

The FDA completed an inspection of Strides Alathur Private Limited on April 5, 2024 in Chengalpattu. 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
April 5, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chengalpattu (India)

Citations

IDCFRDescription
187921 CFR 211.180(c)Records not made readily available to FDA
436821 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy