Cadila Healthcare Limited
Form 483 issued September 5, 2025
- Inspection
- Aug 25 – Sep 5, 2025
- Observations
- 4
- Pages
- 8
- FEI number
- 3013712903
In short: On September 5, 2025, FDA issued a Form 483 with 4 observations to Cadila Healthcare Limited (FEI 3013712903) after an inspection that ran Aug 25 – Sep 5, 2025. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Questions about this 483
What did FDA find at Cadila Healthcare Limited?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
When was Cadila Healthcare Limited inspected by FDA?
The inspection ran Aug 25 – Sep 5, 2025, and the Form 483 is dated September 5, 2025.
How do I get the full Form 483 for Cadila Healthcare 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.