The US Food and Drug Administration (FDA) inspected Strides Pharma’s Puducherry, India, drug manufacturing facility from January 28 to February 5, 2019, and noted several causes for concern.
Primarily, the warning letter highlighted the Indian company’s failure to “establish an adequate quality control unit,” which resulted in the discovery of current good manufacturing practice (cGMP)-related documents being shredded in an ‘uncontrolled’ manner, as well as being entirely discarded.
One particular incident saw FDA inspectors find a binder of cGMP documents in a 55-gallon drum in the company’s scrap yard, which contained records that were dated seven days prior to the agency’s scheduled inspection.
The warning letter noted that the company’s quality unit (QU) had not reviewed the documents prior to disposal.
The FDA concluded, “The uncontrolled destruction of cGMP records, and your lack of adequate documentation practices, raise questions about the effectiveness of your QU and the integrity and accuracy of your cGMP records.”
In further criticism of the company’s manufacturing failures, the FDA stated that it had failed to investigate out-of-specification active pharmaceutical ingredient (API).
The specific API was redacted but the agency found that the company had not evaluated the original failing API sample, instead concluding that an ‘old reagent’ had caused the issue, despite not being able to reproduce the impurity during testing.
Strides had previously notified shareholders that it had received a warning letter from the agency and that this would result in deferrals for 10 pending abbreviated new drug approvals (ANDAs).
In response to the public details revealed by the warning letter, Strides’ company secretary, Manjula Ramamurthy, put out a statement confirming that it had received the warning letter and that it had already clarified the impact on the business without adding any further details.