An inspection conducted in late August 2019 by the US Food and Drug Administration (FDA) at Windlas Healthcare drug manufacturing facility in Dehradun, India, resulted in a Form 483 citing several violations of current good manufacturing practice (cGMP) regulations.
Following the review of the company’s response, the regulatory body issued a warning letter, demanding actions be taken by the company to resolve issues regarding oversight of manufacturing processes and quality assurance.
Among the wrongdoings, the FDA said inspectors saw at their arrival employees moving off-site cartloads of trash bags containing shredded documents, including batch reconciliation forms, cleaning and dispensing logs, training assessments, and scale balance printouts.
Moreover, the regulator reports that an investigator requested to visit a location of the facility, after observing through live-feed cameras “staff expediently signing and passing documents to one another.” However, the investigator was routed to an incorrect area.
This incident resulted in delaying the inspection and preventing contemporaneous verification of the activities performed at the time, stated the FDA.
As a response, the company said that the procedure followed regarding the locations of the cameras, which were installed a week prior to the investigation, was incorrect.
Windlas’ response to the observations was characterized as inadequate, with the regulator placing the firm on Import Alert and withholding any approvals of new drug applications filed by the company until compliance with regulations was met.
