The cleaning procedures are so poor at a Zydus Cadila plant in India that the FDA says a sampling found 10 different tablet products that were cross-contaminated with API residue from another drug during production.
Cadila’s response to the agency was that what the FDA called “significant cross-contamination” didn’t pose a risk to patients, which the agency completely dismissed as scientifically unsound.
The findings were laid out in a recent warning letter that piled problems on top of the plant at Moraiya, Ahmedabad, after a Form 483 had already savaged it for having grimy aseptic equipment and unacceptable work methods that could lead to microbial contamination of sterile injected products.
Cadila acknowledged this month that it had received the warning letter but downplayed the potential impact. It said the action would not hurt its U.S. business and that it expects to continue to produce drugs at the Moraiya facility, its largest serving the U.S. market.
The warning letter ordered Cadila to completely remake its cleaning procedures and explain to the FDA the “worst case” cleaning situations it faced and how it intends to overcome them.
Cadila has for years faced FDA concerns over its manufacturing at different plants. This is the second warning letter in four years for Cadila’s Moraiya plant. It and a sterile injectables facility in Vadodara, India, were called out for manufacturing issues in a warning letter in late 2015.
The FDA also has found issues with Zydus Cadila’s Nesher Pharmaceuticals plant in St. Louis. An inspection there last summer resulted in 11 observations.
Nov 14, 2019