Another US FDA import alert to Indian API plant: Canton Laboratories

The US FDA has issued an import alert of drug products made at Canton Laboratories’ Baroda production facility. Earlier, the API plant has received a warning letter for cGMP violations that included a number of infractions of data integrity. And now, all the drugs and drug ranging from antimicrobials to root canal cleansers, as well as some food and animal products have been banned from import into the US.

Canton Laboratories is leading manufacturers of fine chemicals and bulk drugs with a large share in the indigenous market. The company has four facilities located in the Baroda location which manufactures pharmaceuticals, specialty chemicals and mineral fortifiers etc. The company lists top U.S. Pharmaceutical companies such as Mallinckrodt Pharmaceuticals and Thermo Fisher Scientific laboratory supplying arm, Fisher Scientific as its customers.

FDA has issued an import alert as the company was not able to follow USFDA- mandated good manufacturing practices (cGMP). The warning letter has listed number of violations including the failure to perform laboratory testing of API’s to ensure conformance to specifications and to accurately report the results on Certificates of Analysis (CoA), the failure to maintain complete data derived from the laboratory tests, the failure to ensure equipment is cleaned in a reproducible and effective manner to prevent contamination etc.