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FDA Inspection
•Vitane Pharmaceutical, Inc.•October 23, 2024

Vitane Pharmaceutical, Inc. – FDA Inspection, Oct 23, 2024

Record Details

This FDA Inspection record concerns Vitane Pharmaceutical, Inc., with an inspection on October 23, 2024, issued by the New York District Office, covering human drugs.

Company
Vitane Pharmaceutical, Inc.
Inspection Date
October 23, 2024
Product Type
Human Drugs
Office
New York District Office
People
  • Divek R. Jumani (Company Rep)
  • Gam S. Zamil (Company Rep)
View Company Profile

ID · 133cbd3f-c551-4a74-b323-55c34ef10345

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1252374
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

5
  1. 21 CFR 211.142(b)Storage under appropriate conditions
  2. 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
  3. 21 CFR 211.180(e)Records reviewed annually
  4. 21 CFR 211.84(d)(2)Reports of Analysis (Components)
  5. 21 CFR 211.100(a)Absence of Written Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Vitane Pharmaceutical, Inc.

1
DateClassificationOfficeProject area
March 21, 2024NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
Other documents for Vitane Pharmaceutical, Inc.
  • FDA Inspection 1235772 - 2024-03-21

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