FDA warns API manufacturer about river water as ingredient
The FDA has issued Badrivishal Chemicals & Pharmaceuticals a warning letter regarding numerous violations of manufacturing codes. The most worrying of the warnings being the failure to follow sanitisation procedure in the use of river water as an ingredient in the production of active pharmaceutical ingredients (APIs).
The API manufacturing plant, based in Pune, India, has already been hit with a ban by the FDA from exporting drugs to the US, at the end of last year. The 12,000 square feet facility had attempted to lift the restrictions but the most recent inspection will have gone no way to lifting the hold.
“Our investigators found that you were aware that the total aerobic microbial counts (TAMC) for all in-process water samples had exceeded your limit of colony forming units (cfu)/mL for multiple months. You failed to investigate these deviations”, the FDA noted in its letter to the facility and one of the more alarming features of it.
Beyond failure to test the sanitisation of the water, the company was found to fail to test the quality of the river water, which it stored in a large tank that was ‘open to the environment’.
The report also noted, “Furthermore, your firm did not demonstrate an adequate understanding of the process that your water system relies on to kill microorganisms”.
As well as these manufacturing mistakes, more rudimentary, clerical errors were observed. This included bin bags found filled with torn laboratory and production reports. The information pieced together from these reports was not found to match the official documentation that was presented to the FDA officials.
The facility had previously supplied APIs to countries such as the US, the UK and other European countries. The FDA gave the company 15 days to respond to the letter.