Unilab Chemicals and Pharmaceuticals Private Ltd.

Form 483 issued February 27, 2026

Inspection
Feb 23 – Feb 27, 2026
Observations
5
Pages
7
FEI number
3004985767

In short: On February 27, 2026, FDA issued a Form 483 with 5 observations to Unilab Chemicals and Pharmaceuticals Private Ltd. (FEI 3004985767) after an inspection that ran Feb 23 – Feb 27, 2026.

What FDA observed

Preview: the opening words of each observation
  1. 01

    There is a failure to establish the reliability of the component…

  2. 02

    There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…

  3. 03

    The responsibilities and procedures applicable to the quality control unit are not in…

  4. 04

    GMP training is not conducted with sufficient frequency to assure that employees remain familiar with cGMP…

1 more observation

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at Unilab Chemicals and Pharmaceuticals Private Ltd.?

FDA listed 5 observations on this Form 483. The opening words of each observation are shown on this page.

When was Unilab Chemicals and Pharmaceuticals Private Ltd. inspected by FDA?

The inspection ran Feb 23 – Feb 27, 2026, and the Form 483 is dated February 27, 2026.

How do I get the full Form 483 for Unilab Chemicals and Pharmaceuticals Private Ltd.?

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.

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