Zydus Lifesciences Limited
Form 483 issued March 27, 2024 · Matoda, India
- Inspection
- Mar 18 – Mar 27, 2024
- Investigators
- Lori M. Newman· Sean R. Marcsisin
- Observations
- 4
- Pages
- 6
- FEI number
- 3007621329
In short: On March 27, 2024, FDA issued a Form 483 with 4 observations to Zydus Lifesciences Limited in Matoda, India (FEI 3007621329) after an inspection that ran Mar 18 – Mar 27, 2024. The investigators were Lori M. Newman and Sean R. Marcsisin. Most observations concern facilities & equipment and production.
At a glance
3 of 4 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…
- 04
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
This inspection in context
Lori M. Newman
18 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmZydus Lifesciences Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zydus Lifesciences Limited?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Zydus Lifesciences Limited?
Lori M. Newman and Sean R. Marcsisin are named on this Form 483, for the inspection of Mar 18 – Mar 27, 2024. Each investigator has a profile showing what they cite most.
When was Zydus Lifesciences Limited inspected by FDA?
The inspection ran Mar 18 – Mar 27, 2024, and the Form 483 is dated March 27, 2024.
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.