Zydus Cadila injectables plant slapped with FDA warning letter over contamination risks

Cadila Moraiya
Zydus Cadila's plant in Moraiya has been issued an FDA warning letter. It had been tagged with a warning letter in 2015 as well. (Cadilia)

India’s Zydus group began steps to fix its perpetually troubled sterile manufacturing plant in Moraiya as soon as an FDA inspector uncovered manufacturing issues this spring. Its efforts failed to do the job.   

Zydus Cadila in a public filing (PDF) today says the agency has issued a warning letter for the facility, its second in four years. The drugmaker claims the action will not affect its business in the U.S. and that it expects to continue to produce drugs at the Moraiya facility, its largest feeding drugs to the U.S. market.  

RELATED: Cadila reports Ahmedabad plant gets EIR from FDA, specifies it’s not part of Moraiya site

Cambrex Webinar

Understanding the Importance of Crystallization Processes to Avoid Unnecessary Cost, Risk and Development Delays

Wednesday, May 27, 2020 | 10am ET / 7am PT

A well-developed crystallization process can produce suitable particles that can facilitate consistent filtration, drying and formulation of the API and allow confident and reliable manufacturing of the final drug product, while avoiding unnecessary cost, risk and development delays.

Cadila didn’t say what the warning letter criticized, but it didn’t have to. The plant was savaged in a 14-observation Form 483 issued in May. The citation listed a range of problems from finding grimy aseptic equipment to worker methods which could lead to microbial contamination. It went so far as to call out workers in one area that it believes were responsible for microbial contamination at the plant. 

“The EM data reveal certain individuals who appear to be a source for the Bacillus and Pseudomonas microbial contamination in the Grade B and Grade A manufacturing areas,” the citation says. 

RELATED: Cadila's U.S. facility in St. Louis cited by FDA for 11 observations: report

It is not the first warning letter 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. 

Cadila’s manufacturing failings are not confined to its operations in India either. Just weeks after the Moraiya plant was inspected, the FDA went through Zydus’ Cadila’s Nesher Pharmaceuticals plant in St. Louis, Missouri. That facility was hit with 11 observations. 

Read more on

Suggested Articles

CanSino Bio, Moderna and a collaboration between Oxford Univeristy and AstraZeneca are frontrunners, but they all face hurdles shared and unique.

Novavax will shell out $167 million for Czech manufacturer Praha Vaccines in a move to boost production of a COVID-19 vaccine past 1 billion doses.

As the election nears, and amid the drumbeat of COVID-19 news, the Trump administration unveiled a new drug pricing initiative.