FDA Inspection 1251393 — Intercos America, Inc.

Intercos America, Inc. — FEI 3003361127

The FDA completed an inspection of Intercos America, Inc. on October 9, 2024 in Congers, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 9, 2024
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Congers, NY (United States)

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records