The US Food and Drug Administration (USFDA) has issued a warning letter to Badrivishal Chemicals & Pharmaceuticals for violating current good manufacturing practice norms at its plant near Pune.
In the letter to the company's Chief Executive Officer Deepak Rawat, the USFDA said inspectors during inspection from August 16 to 19, 2016, found "significant deviations" from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (APIs) at the plant.
Elaborating on the violations at the plant, the USFDA noted that the company failed to validate and monitor the water purification system to ensure that water is of appropriate quality and suitable for its intended use.
"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," it added.
The other violations include the firm's failure to prepare, review, and approve documents related to the manufacturing of APIs.
"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 US health regulator said.
The information on these discarded, torn documents did not match the official records, it added.
"Your quality unit did not investigate these discrepancies," the USFDA noted.
Besides, the inspectors identified failure on the part of the company to verify the suitability of analytical methods. Also, the firm failed to adequately investigate critical deviations, it said.
Until the company corrects all violations and deviations completely and the USFDA confirms its compliance with CGMP, it may withhold approval of any new applications, the regulator said.
Failure to correct these deviations may also result in FDA continuing to refuse admission of articles manufactured at the plant into the US, it added.