Badrivishal Receives FDA Warning Letter for Indian Manufacturing FacilityBy
Badrivishal Chemicals & Pharmaceuticals, a Talegaon Dabhade, India-headquartered manufacturer of active pharmaceutical ingredients (APIs) and specialty chemicals, has received a Warning Letter from the US Food and Drug Administration (FDA) for cGMP violations at the company’s Taluka Maval, India drug manufacturing facility. The violations were noted during an FDA inspection of the facility in August 16-19, 2016, and the agency reviewed Badrivishal’s September 8, 2016 response.
During its inspection, the FDA made several observations, namely that Badrivishal’s water purification system was not adequately monitored and controlled, which poses a risk to the safety of the drugs produced in the facility; that a large number of trash bags on the property contained torn original laboratory and production records that did not match official records; that analytical testing methods by a contract testing laboratory were not verified as suitable for their intended use; and that the company failed to investigate unexplained discrepancies in run times during impurity testing chromatograms for at least six batches over at least three months, as well as aborted runs and reprocessing of data.
Badrivishal is required to include the following in its response to the FDA:
- a plan to address the open source-water storage tank and a status update of a performance qualification the company initiated in March 2016
- a corrective and preventive action plan if source water test results exceed the limits and a scientific rationale for setting microbial limits
- details and a summary of the system that was established for reviewing cGMP documents to ensure documents are tracked and disposed of properly and the procedure for handling discrepancies and ensuring ongoing quality unit oversight
- clarification on which company performed the analytical test verification and internal review results of all other test methods
- a description of corrective and preventive actions taken that show the company’s contract testing laboratory provider is qualified to test the drugs produced at Badrivishal’s facility
Source: Food and Drug Administration