Zydus Lifesciences continues to be under intense scrutiny from the FDA, which hit the Indian drugmaker’s production facility in Jarod with a warning letter.
Earlier this year, Zydus was slammed within the span of one month with a pair of Form 483 reprimands following inspections at separate manufacturing sites in India. At the time, the FDA outlined issues ranging from unqualified employees performing sample collections to improper evaluations of drug batches.
This time, the company’s injectables facility in Jarod near Vadodara was given a warning letter in the wake of an April 15-23 inspection, Zydus said in a financial filing dated August 30.
“The company will take all necessary steps to work with U.S. FDA towards earliest remediation of the above facility,” Zydus said.
Although no specific violations were cited in the company’s response, Zydus said the most recent FDA reprimand didn’t contain any data integrity issues.
While the warning won’t impact existing supplies from the facility, it does, however, restrict new launches, “which is critical for business growth in the U.S. market," Zydus added in the filing.
In early May, a Zydus site in Gujarat, India, was hit with a Form 483 that stemmed from an April inspection. During the visit, FDA inspectors uncovered ten observations of manufacturing procedural shortfalls.
For example, the regulator found that drug lots produced on equipment that had been exposed to cross-contamination were released to the U.S. without a thorough investigation.
Three weeks prior to that rebuke by the FDA, the company’s facility in Matoda, India, received a Form 483 following a March inspection. That visit by FDA inspectors resulted in four observations, including Zydus' failure to clean and maintain equipment.