- The Food and Drug Administration sent Strides Pharma Science a warning letter regarding violations found during an inspection in January and February of this year.
- The agency’s letter, dated July 1, outlined problems in the Indian generic drug manufacturer’s quality unit, including "evidence of uncontrolled shredding of documents."
- "Strides is committed to the highest standards of quality and compliance and will work collaboratively with the FDA to resolve all issues addressed in the warning letter," the company said in a letter to the Indian stock exchange.
The FDA warned Strides it can withhold approvals of new products as a result of the violations. Because of the warning, Strides said 10 products pending approval will get deferred. Another six drugs produced at the Puducherry site won’t be affected, the company said.
Strides, which makes generic products ranging from ibuprofen to anti-diabetic medicines, isn’t alone in drawing the FDA’s ire over document shredding. In 2017, the agency warned both Indian drugmaker Hetero Labs and Italy’s FACTA Farmaceutici about the same issue.
In the case of Strides, the FDA inspection found multiple bags of drug production, quality and lab operation documents awaiting shredding. A binder with batch records found in a 55-gallon drum in the scrap yard included documents dated Jan. 21, 2019, seven days before the FDA inspection began.
The response from Strides that the binder was "inadvertently come [sic] to scrap yard" is inadequate, the FDA said in its warning letter.
"You did not assess other documents found in the scrapyard, nor did you assess how poor documentation practices affected distributed drug product or how you would strengthen" quality unit oversight, the agency said.
Strides also failed to properly investigate a case where an unknown impurity exceeded specifications in a drug batch, the FDA said. And the agency said the company’s quality system "does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness and quality of drugs you manufacture."
The FDA "strongly" recommended that Strides retain a consultant to help fix the problems at the plant and requested a response to the warning letter within 15 working days.