The US regulator criticized Badrivishal in a warning letter this week, explaining the lack of monitoring combined with the use of river water in cleaning processes means the firm cannot ensure the safety of products made at its site in Induri.
The agency wrote: “During the inspection, our investigators found that your water purification system was not adequately monitored and controlled. Because you use water as a drug component and for cleaning your facility and equipment, these failures pose significant risk to the safety of your drugs.”
In addition, the Food and Drug Administration (FDA) raised concerns about water storage, sanitization and testing practices used at the site, pointing out that staff failed to investigate out-of-spec microbiological test results.
The agency also pointed out that contaminated water at production sites has been the cause of a number of recalls, citing the outbreak of Burkholderia cepacia infections in the US as an example.
The agency also said Badrivishal failed to properly document the production of active pharmaceutical ingredients (APIs), adding the firm had not investigated discarded water testing reports found at site.
“On August 16, 2016, our investigators found a large number of trash bags behind a building on your property. The trash bags contained torn original laboratory and production records, such as analytical test reports, water testing reports, and sample notebooks.
“The information on these discarded, torn documents did not match the official records. Your quality unit did not investigate these discrepancies.”
The FDA gave the API Badrivishal days to respond.
The firm – which has been banned from shipping products to the US since December - did not respond to a request for comment.