Yet another facility run by an Indian drugmaker has been tagged by the FDA. The latest belongs to Cadila Healthcare, which was cited by the FDA for failing to follow good manufacturing practices at a new facility designed to make injectable meds for sale in the US. More specifically, a June 21 warning letter cited problems with microbiologists failing to follow basic procedures.
For instance, microbiologists reported that were no problems with microbiological plates when, in fact, a colony-forming unit - which is a measure of viable bacterial or fungal numbers - was found. And a microbiological growth was incorrectly identified and reported as a typical microorganism when compared with an in-house library of typical environmental flora.
This may seem like so much inside baseball, but as the FDA notes in its letter, "accurate and reliable microbiological data is essential to support the aseptic processing operations used during the manufacturing of sterile finished drug products intended for distribution in the US." In other words, this is serious business and may prompt the agency to prevent Cadila meds from entering the US (read the letter).
Cadila isn't the only Indian drugmaker to face FDA scrutiny over manufacturing practices as the agency struggles to assert its authority over foreign drugmakers and ingredient suppliers in the wake of ongoing controversy and concerns about the pharmaceutical supply chain (read here). A notable instance was the contaminated Heparin scandal that was blamed for dozens of deaths (look here).
In recent months, the agency has taken action against Dr. Reddy's Laboratories for failing to properly validate methods for testing active pharmaceutical ingredients at a plant in Mexico (see this) and restricted imports from a plant run by Aurobindo Pharma, which supplies some meds to Pfizer (read here). Meanwhile, Ranbaxy Laboratories continues to chafe under an import ban on 30 meds issued three years ago for allegedly falsifying records resulting in the production and sale of meds failing to meet FDA standards. A resolution, however, is reportedly close at hand (see this).