Zydus Life said the US Food and Drug Administration (USFDA) conducted the good manufacturing practices (GMP) surveillance inspection at its Unit 9 facility at Zydus Biotech Park in Changodar, Ahmedabad, from April 27 to May 5, 2026.
The inspection closed with seven observations. Zydus Life said there were no data integrity-related observations and that it will work closely with the USFDA to address the same expeditiously.
Recent USFDA inspection history
Here is a timeline of key inspections across Zydus units over the past two years:
February 2026
Unit 9 — Pre-Approval Inspection (PAI) – 0 observations
Inspection conducted between February 16 – February 19, 2026 concluded with zero observations, clearing the path for new US market approvals in the injectable segment.
September 2025
Injectable facility, Jarod, Vadodara – 4 observations
Inspection held between August 25 – September 5, 2025 concluded with four observations, none related to data integrity. Company pledged prompt resolution.
June 2025
Oncology injectable facility, SEZ 1, Matoda, Ahmedabad – two observations
The follow-up GMP inspection, between June 9 – June 18, 2025 closed with just two minor observations and no data integrity issues — a significant improvement from the 2024 inspection at the same site.
April 2025
API manufacturing unit, Dabhasa, Gujarat – Six observations
Surveillance inspection conducted between April 21 – April 25, 2025. Six observations were issued but none were data integrity-related. Zydus reaffirmed confidence in addressing them quickly.
April 2024
Injectable facility, Jarod, Vadodara – 10 observations
Ten observations were issued following this inspection — the highest observation count in the recent period.
March 2024
Oncology plant (sterile), Matoda, Ahmedabad Multiple observations
Inspection conducted between March 18 – March 27, 2024.
FDA observations included concerns around aseptic processing conditions, environmental monitoring, and equipment cleaning protocols.
Stock reaction
Zydus Life shares were trading 2.8% up at ₹937.55 apiece at 12.05 pm on Wednesday. The stock has gained 2.4% this year, so far.
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