Regulatory problems are piling up for the sterile manufacturing operations of India’s Aurobindo, which has had another plant cited by the FDA.
The drugmaker in a fiilng today acknowledged (PDF) that an FDA inspection last month at its sterile formulations plant in Pashamylaram, Hyderabad, ended with a Form 483 listing 9 observations.
The company said that it was working to resolve the issues and that none of the observations related to data integrity and none were repeats. But among other problems, the plant was cited for issues that the FDA said could lead to product contamination, reported the Business Standard, which obtained a copy of the Form 483.
The FDA noted the plant was not cleaning equipment regularly and an inspector also found signs of “vermin,” including rodents and insects, in building used for manufacturing, packaging and storage, the newspaper said.
Aurobindo last year received a Form 483 for another sterile manufacturing plant in nearby Bachupally. Those six observations also included problems in procedures that are supposed to prevent microbiological contamination of sterile products.
The findings come as the India drugmaker is expanding its biologics and sterile capabilities in the U.S. and Europe. Last year it, acquired four biosimilar products from Visp, Switzerland-based TL Biopharmaceutical and said it was building a manufacturing plant to support the production of those and eight others it has under development.
The company also has several projects going on in the U.S. It had already broken ground on 567,000-square-foot sterile manufacturing facility at its site in New Jersey that would employ up to 500, when last year its announced plans to build a second sterile injectables plant at the site.