Zydus Lifesciences Limited
Form 483 issued March 24, 2023 · Ahmedabad, India
- Observations
- 3
- Pages
- 5
- FEI number
- 3007938603
In short: On March 24, 2023, FDA issued a Form 483 with 3 observations to Zydus Lifesciences Limited in Ahmedabad, Gujarat (FEI 3007938603). Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
Questions about this 483
What did FDA find at Zydus Lifesciences Limited?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.
When was Zydus Lifesciences Limited inspected by FDA?
This Form 483 is dated March 24, 2023.
How do I get the full Form 483 for Zydus Lifesciences 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.