Zydus Lifesciences Limited
Form 483 issued May 5, 2026 · Ahmedabad, India
- Inspection
- Apr 27 – May 5, 2026
- Investigators
- Brandy N. Lepage· Jessica S. Estriplet
- Observations
- 2
- Pages
- 7
- FEI number
- 3012977526
In short: On May 5, 2026, FDA issued a Form 483 with 2 observations to Zydus Lifesciences Limited in Ahmedabad, India (FEI 3012977526) after an inspection that ran Apr 27 – May 5, 2026. The investigators were Brandy N. Lepage and Jessica S. Estriplet. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.113(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmZydus Lifesciences Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zydus Lifesciences Limited?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Zydus Lifesciences Limited?
Brandy N. Lepage and Jessica S. Estriplet are named on this Form 483, for the inspection of Apr 27 – May 5, 2026. Each investigator has a profile showing what they cite most.
When was Zydus Lifesciences Limited inspected by FDA?
The inspection ran Apr 27 – May 5, 2026, and the Form 483 is dated May 5, 2026.
How do I get the full Form 483 for Zydus Lifesciences Limited?
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