Just before the end of 2015, the US Food and Drug Administration (FDA) warned two Indian pharmaceutical manufacturing facilities from Cadila Healthcare for major good manufacturing practice (GMP) violations.
The warning letter (not to be confused with the warning letter for another Indian manufacturer that goes by the name of Cadila Pharmaceuticals) caps a year of increased scrutiny for Indian drug manufacturers from FDA.
In particular, FDA found that after the company restarted production of warfarin sodium tablets (following out-of-specification results associated with potency and content uniformity specifications), additional lots failed, revealing “inadequate process controls and complaint and failure investigations related to warfarin tablets.”
“These persistent failures indicate that your manufacturing process is not in a state of control,” the agency warns.
In addition, over a three-year period, Cadila received nine consumer complaints related to potential mix-ups of products from different pharmacies and distributors.
“During your investigations of these complaints, you documented that some of the mixed-up drugs were manufactured on adjacent equipment lines, but you never completed the root cause analysis. Thus, it remains unknown whether the mix-ups were caused by inadequate cleaning procedures, personnel flow, equipment suitability, material flow, line segregation, line-clearance documentation, or something else,” FDA says.
But what was perhaps most troubling was that FDA investigators found “several plastic bags filled with paperwork and other scrapped items in the scrap yard. One item was a torn notebook of deficiencies recorded during review of your batch manufacturing records.”
Cadila apparently told FDA that these were personal notebooks intended only for meeting and other discussion notes, but the agency says that does not explain why production personnel used unofficial paper for documenting GMP data.
On New Year’s Eve Cadila disclosed that it is working with the agency to fix the problems cited and that there are no products in the US market that use active pharmaceutical ingredients (APIs) produced at one of the sites where API analyses failed.