Zydus Lifesciences Limited
Form 483 issued August 5, 2022 · Ahmedabad, India
- Inspection
- Jul 26 – Aug 5, 2022
- Observations
- 4
- Pages
- 8
- FEI number
- 3002984011
In short: On August 5, 2022, FDA issued a Form 483 with 4 observations to Zydus Lifesciences Limited in Ahmedabad, Gujarat (FEI 3002984011) after an inspection that ran Jul 26 – Aug 5, 2022. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Time limits are not established when appropriate for the completion of each production phase to assure…
- 04
Written procedures are lacking which describe in sufficient detail the identification, handling and sampling of components…
This inspection in context
Questions about this 483
What did FDA find at Zydus Lifesciences Limited?
FDA listed 4 observations on this Form 483, mostly about production, quality system and materials. The opening words of each observation are shown on this page.
When was Zydus Lifesciences Limited inspected by FDA?
The inspection ran Jul 26 – Aug 5, 2022, and the Form 483 is dated August 5, 2022.
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.