FDA Inspection 1092770 — Unexo Life Sciences Private Limited

Unexo Life Sciences Private Limited — FEI 3013514280

The FDA completed an inspection of Unexo Life Sciences Private Limited on May 10, 2019 in New Delhi. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
May 10, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
New Delhi (India)

Citations

IDCFRDescription
113321 CFR 211.25(a)GMP Training Frequency
127021 CFR 211.68(b)input/output verification
203421 CFR 211.194(d)Laboratory equipment calibration records

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.