Vantive Manufacturing (Thailand) Company – FDA Inspection, Dec 3, 2024

Record Details

This FDA Inspection record concerns Vantive Manufacturing (Thailand) Company, with an inspection on December 3, 2024, issued by the Office of Inspections and Investigations, covering human drugs.

Company: Vantive Manufacturing (Thailand) Company
Inspection Date: December 3, 2024
Product Type: Human Drugs
Office: Office of Inspections and Investigations
People: David J. Gomes (Issuing Officer)
Tamil Arasu (FDA Associated Person)
Wayne D. Mcgrath

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ID · 4c3478f7-fce9-4a8d-a35c-a13a81d5c8cb

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1255783
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 211.84(d)(3)Testing Containers & Closures Conformity with Specs
21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 211.194(a)Complete test data included in records
21 CFR 211.113(b)Procedures for sterile drug products
21 CFR 211.192Investigations of discrepancies, failures
21 CFR 211.22(d)Procedures not in writing, fully followed

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FDA Inspection

Vantive Manufacturing (Thailand) CompanyDecember 3, 2024