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FDA Inspection
•INTERVEIN RESEARCH LABS PRIVATE LIMITED•May 16, 2025

INTERVEIN RESEARCH LABS PRIVATE LIMITED – FDA Inspection, May 16, 2025

Record Details

This FDA Inspection record concerns INTERVEIN RESEARCH LABS PRIVATE LIMITED, with an inspection on May 16, 2025, issued by the Office of Inspections and Investigations, covering human drugs.

Company
INTERVEIN RESEARCH LABS PRIVATE LIMITED
Inspection Date
May 16, 2025
Product Type
Human Drugs
Office
Office of Inspections and Investigations
Person
  • Marcellinus D. Dordunoo (FDA Associated Person)
View Company Profile

ID · 4106f38f-1771-4d55-ba98-d35d401b8354

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1269556
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 211.142(b)Storage under appropriate conditions
  2. 21 CFR 211.68(a)Calibration/Inspection/Checking not done
  3. 21 CFR 211.22(d)Procedures not in writing, fully followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of INTERVEIN RESEARCH LABS PRIVATE LIMITED

1
DateClassificationOfficeProject area
June 25, 2024VAIOffice of Inspections and InvestigationsGeneric Drug Evaluation
Other documents for INTERVEIN RESEARCH LABS PRIVATE LIMITED
  • FDA Inspection 1242128 - 2024-06-25

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