Indian Manufacturer Smacked With 483 for Not Rejecting APIs
Nosch Labs, a maker of active pharmaceutical ingredients, was hit with a five-observation FDA Form 483 after workers at its Veliminedu Village, Chityal Madal, India, facility were observed passing off APIs that failed to meet quality control standards.
During the April 27 to May 1 inspection, FDA investigators found that analysts employed by the firm had repeatedly altered acquisition dates of APIs in 2012. There were also discrepancies in the testing records of APIs that the company couldn’t explain.
On two occasions, inconsistencies were noticed in the balance weights of APIs on five balance weight printouts. Those issues should have resulted in rejection of the APIs, the 483 says.
Nosh also lacked controls to ensure that electronic records are equivalent to paper records and to prevent personnel from modifying or deleting information. And the firm tested its stability chambers without having a sample load inside.
Also missing were procedures for cleaning equipment and for monitoring the performance of manufacturing processes that could cause variations in APIs.
Nosch produces APIs used in drugs to treat ulcers, migraines, psychosis and hypertension.
Foreign facilities, including API manufacturers, have been under increased scrutiny by the FDA for data issues, resulting in recent warning letters for firms in the Czech Republic, Thailand and China.
The company did not return a request for comment by press time. View the 483 at www.fdanews.com/07-16-2015-NoschLabs.pdf. — Kellen Owings