Zydus Lifesciences Limited
Form 483 issued August 10, 2018 · Thane, India
- Inspection
- Aug 10, 2018
- Investigator
- William Leonard
- Observations
- 4
- Pages
- 2
- FEI number
- 3006809732
In short: On August 10, 2018, FDA issued a Form 483 with 4 observations to Zydus Lifesciences Limited in Thane, Maharashtra (FEI 3006809732) after an inspection that ran Aug 10, 2018. The investigator was William Leonard. Most observations concern production and materials.
At a glance
Production and materials 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
Munufacturing procedures are not…
- 02
Critical weighing, measuring, or operations should be witnessed or subjected…
- 03
Written procedures describing the receipt, identification, quarantine, storage, handling, sampling, testing, and approval or rejection of…
- 04
Laboratory controls were not followed and documented at…
This inspection in context
William Leonard
17 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
The firmZydus Lifesciences Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
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 production, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Zydus Lifesciences Limited?
William Leonard is named on this Form 483, for the inspection of Aug 10, 2018. Each investigator has a profile showing what they cite most.
When was Zydus Lifesciences Limited inspected by FDA?
The inspection ran Aug 10, 2018, and the Form 483 is dated August 10, 2018.
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.