Vitane Pharmaceutical, Inc
Form 483 issued October 23, 2024 · Congers, New York
- Inspection
- Oct 15 – Oct 23, 2024
- Investigators
- Divek R. Jumani· Gam S. Zamil
- Observations
- 5
- Pages
- 6
- FEI number
- 3009790403
In short: On October 23, 2024, FDA issued a Form 483 with 5 observations to Vitane Pharmaceutical, Inc in Congers, New York (FEI 3009790403) after an inspection that ran Oct 15 – Oct 23, 2024. The investigators were Divek R. Jumani and Gam S. Zamil. Most observations concern materials and production.
At a glance
Materials and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality…
This inspection in context
Divek R. Jumani
5 documents · 2024–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New York.
The firmVitane Pharmaceutical, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vitane Pharmaceutical, Inc?
FDA listed 5 observations on this Form 483, mostly about materials, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Vitane Pharmaceutical, Inc?
Divek R. Jumani and Gam S. Zamil are named on this Form 483, for the inspection of Oct 15 – Oct 23, 2024. Each investigator has a profile showing what they cite most.
When was Vitane Pharmaceutical, Inc inspected by FDA?
The inspection ran Oct 15 – Oct 23, 2024, and the Form 483 is dated October 23, 2024.
How do I get the full Form 483 for Vitane Pharmaceutical, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.