Zydus Lifesciences shares will be in focus after the US Food and Drug Administration (FDA) issued five observations following an inspection of the company's Moraiya facility in Gujarat.
The inspection was conducted between October 5 and October 13, 2026, and highlighted concerns related to data integrity, quality control procedures and manufacturing practices at the facility, sources said.
Among the key observations, the US FDA flagged instances where microbial growth detected during testing was not accurately documented in laboratory records. The regulator also raised concerns over an inadequate investigation into a metal shaving found in a tablet, an incident that had resulted in a Class II recall.
The inspection further identified instances where multiple batches that exceeded established assay control limits were released into the US market without adequate investigations to determine the root causes.
Additionally, the US FDA noted the absence of written procedures for identifying, investigating and reporting suspected or illegitimate drug products.
The regulator also flagged deficiencies in the verification of Fourier-transform infrared (FTIR) instruments used for raw material identification. According to the observations, documented performance verification of these instruments had not been carried out for three years.
Another concern related to the continued reduction in testing of incoming raw materials despite previous failures to meet specifications, which was inconsistent with the company's established procedures.
The observations could draw investor attention to the company's regulatory compliance and quality control processes, particularly given the significance of the Moraiya facility to its US business. Approximately 45% of Zydus Lifesciences' US sales are attributed to products manufactured at the facility.
At 11:45 AM, Zydus Lifesciences share price was trading 0.90% higher at Rs 1,138.00 apiece on the BSE.
ALSO READ: BSE Share Price Jumps Over 4% After Motilal Oswal Upgrades To 'Buy', Sees Over 23% Upside
Essential Business Intelligence, Sharp Market Insights, Practical Personal Finance Advice, Daily Fuel, Gold and Silver Prices and Latest Stories — On NDTV Profit.