FDA Warns Indian Drugmaker for CGMP Violations
The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Nandore, India-based Wilson Medicine for significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.Following an inspection from 26 February to 1 March, FDA investigators found the company not only did not demonstrate that its manufacturing processes are reproducible and controlled to consistently yield drugs of uniform character and quality, but also did not conduct equipment qualification.
“Your response is inadequate because you failed to provide a detailed process performance qualification protocol and an overall program for assuring ongoing maintenance of a validated process,” FDA said.
The company was also found to not have validated or verified test methods used to determine the acceptability of drug products prior to release. FDA further said the company did not conduct cleaning validation studies to demonstrate that its cleaning procedures for non-dedicated production equipment are adequate to prevent potential cross-contamination at the facility.
In response to the warning letter, FDA is calling on the company to provide, among other things, an independent assessment of all test methods and a comprehensive independent review of Wilson’s “entire laboratory system, and a corrective action and preventive action (CAPA) plan that ensures full remediation of the laboratory operation. For example, the review of your laboratory system should include, but not be limited to, the suitability of all laboratory equipment, a fully remediated calibration program, staff competencies, supervisory oversight, data systems, and other elements of laboratory control.”
Wilson Medicine Company 9/11/18