The FDA has suggested an Indian API maker hire a consultant that understands FDA regulations after finding the company didn’t have a grasp of some basic requirements, including how to make sure the water that comes from a nearby river is sanitary before using it to make its products.
In a warning letter to Badrivishal Chemicals & Pharmaceuticals, the FDA said its plant in Maharashtra has been using the river water since 2014 without scientific evidence that the system is capable of producing water that meets quality standards.
That's despite the fact that the water passes through farmland where it is subject to agricultural runoff and animal waste, and is stored in a tank with a hole in it that does not protect it from dirt and debris. The FDA pointed out the API maker sometimes sanitized water for less than 10 minutes before use, with no scientific evidence that would get it clean.
In fact, the letter said, plant employees knew the water for months was out of spec for total aerobic microbial counts when it was used in production, but they didn’t investigate or even seem to understand the process that the plant’s water system relies on to kill microorganisms.
The FDA pointed out that contaminated water was found to be the source of Burkholderia cepacia contamination by other drugmakers, referring to a hospital outbreak last year that sickened dozens of patients before it was tracked back to a U.S. API maker.
But water was only one of the problems FDA investigators found during its August 2016 plant inspection at Badrivishal Chemicals & Pharmaceuticals.
Records were found in trash bags behind a building that showed test results that were different from what had been officially recorded. And the facility was not investigating deviations reported to it by its testing lab because it didn’t have anyone with the expertise to do that.
Needless to say, the FDA gave the drugmaker a long list of responses it wants and actions to take.