V-Ensure Pharma Technologies Pvt Limited
Form 483 issued May 17, 2024 · Raigad, India
- Inspection
- May 13 – May 17, 2024
- Investigators
- Alan A. Rivera· Angelica M. Hernandez
- Observations
- 1
- Pages
- 2
- FEI number
- 3012155344
In short: On May 17, 2024, FDA issued a Form 483 with 1 observation to V-Ensure Pharma Technologies Pvt Limited in Raigad, Maharashtra (FEI 3012155344) after an inspection that ran May 13 – May 17, 2024. The investigators were Alan A. Rivera and Angelica M. Hernandez. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.166 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written stability program does not assure testing of the drug product in the same container-closure…
This inspection in context
Alan A. Rivera
16 documents · 2022–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmV-Ensure Pharma Technologies Pvt Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at V-Ensure Pharma Technologies Pvt Limited?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected V-Ensure Pharma Technologies Pvt Limited?
Alan A. Rivera and Angelica M. Hernandez are named on this Form 483, for the inspection of May 13 – May 17, 2024. Each investigator has a profile showing what they cite most.
When was V-Ensure Pharma Technologies Pvt Limited inspected by FDA?
The inspection ran May 13 – May 17, 2024, and the Form 483 is dated May 17, 2024.
How do I get the full Form 483 for V-Ensure Pharma Technologies Pvt Limited?
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.