V-Ensure Pharma Technologies Pvt Limited
Form 483 issued January 27, 2023 · Raigad, India
- Inspection
- Jan 23 – Jan 27, 2023
- Observations
- 1
- Pages
- 2
- FEI number
- 3012155344
In short: On January 27, 2023, 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 Jan 23 – Jan 27, 2023. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records are not made of…
This inspection in context
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 quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was V-Ensure Pharma Technologies Pvt Limited inspected by FDA?
The inspection ran Jan 23 – Jan 27, 2023, and the Form 483 is dated January 27, 2023.
How do I get the full Form 483 for V-Ensure Pharma Technologies Pvt Limited?
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