The warning letter addressed to Arun Kumar, CEO and MD of the company, was issued on July 1 said its investigator found a blue binder containing CGMP records, including batch records for US drug products, discarded with other records in a 55-gallon drum in the scrap yard
The USFDA in its warning letter against Strides Pharma’s Puducherry formulation plant has pointed out significant violations of current good manufacturing practice (CGMP), including data integrity lapses.
"During the inspection, our investigator observed discarded CGMP documents and evidence of uncontrolled shredding of documents," USFDA said in its warning letter.
The warning letter, addressed to Arun Kumar, CEO and MD of the company, was issued on July 1. USFDA said its investigator found a blue binder containing CGMP records, including batch records for US drug products, discarded with other records in a 55-gallon drum in the scrap yard.
The warning letter added that the CGMP documents in the binder were dated as recently as January 21, 2019 or seven days before the inspection.
Moneycontrol has seen a copy of the warning letter.
The Puducherry facility was inspected in February this year and was classified as Official Action Indication (OAI) in May.
"The uncontrolled destruction of CGMP records and your lack of adequate documentation practices raise questions about the effectiveness of your Quality Unit (QU) and the integrity and accuracy of your CGMP records," the regulatory agency said.
USFDA was not convinced with Strides' response to data integrity allegations. The agency said the firm’s quality systems are inadequate to ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.
USFDA also expressed concern over deficiencies in investigating out-of-specification (OOS) results of drug batches.Spillover effect
The USFDA has sought Strides to do a current risk assessment of the potential effects of the observed failures on the quality of their drugs.
"Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations," USFDA said.
The USFDA also has widened the net. It had asked Strides to come-up with the details of global corrective action and preventive action plan.
This includes a management strategy for the firm with details of global corrective action and preventive action plan.
"The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm, including microbiological and analytical data, manufacturing records, and all data submitted to FDA," it stated.
Data integrity violations at Strides’ Puducherry plant came as a setback to the industry.
Data integrity or data reliability issues which had constituted about half of the Form 483 observations made by USFDA in 2016, reduced significantly in 2018 to 17 percent. Companies have worked on automating data collection, eliminated unauthorised access and trained people.
Strides supplies six products to the US from this facility. The warning letter would not impact existing sales, but puts a lid on new approvals.
Around 10 abbreviated new drug applications (ANDAs) are pending for approval from this site, and these would be delayed.
Strides has been aggressive on expanding in the US market, as it constitutes around 40 percent of Strides Rs 3,011.7 crore revenue.
"The company had a shaky track record of compliance in the past, but it worked on putting things in order, this is a setback," said quality expert who didn't want to be named.
"Warning letters centred around data integrity generally take two to four years to resolve," the person above said.Strides' three injectable plants in Bengaluru, that were sold to Mylan in a deal valued at $1.6 billion in December 2013, had faced USFDA warning letter. Mylan had to hold back a portion of the proceeds claiming compensation for the remediation costs.The Great Diwali Discount!
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