Drugmaker Shredded Quality Documents Ahead of FDA Inspection
(Bloomberg) -- An India-based company that sells numerous drugs in the U.S., including ibuprofen, was caught attempting to dispose of quality-control records, calling into question the safety of its medicines.
U.S. Food and Drug Administration inspectors said they found what appeared to be records awaiting shredding at Strides Pharma Science Ltd.’s manufacturing facility in Puducherry, the agency said in a warning letter to Chief Executive Officer Arun Kumar made public on Tuesday. Discarded records were also found in a 55-gallon drum in the company’s scrap yard, the letter said. Ibuprofen is among the drugs the company makes at the Puducherry plant.
The destruction of quality-control paperwork and a lack of adequate documentation that its medicines are safe “raise questions about the effectiveness” of Strides’s quality unit “and the integrity and accuracy” of its data, FDA’s Francis Godwin, director of the Office of Manufacturing Quality, wrote in the warning letter.
Strides didn’t immediately respond to a request for comment.
Drugmakers around the world are facing questions about their quality-control procedures amid a yearlong recall of heart pills contaminated with probable carcinogens. Most of those pills were produced in India and China, where U.S. regulators have sometimes struggled to oversee companies whose workers have actively taken steps to mislead them.
A Bloomberg investigation this year has documented an industrywide problem of companies ignoring test results showing that some generic drugs fail to measure up to U.S. standards. Drugmakers in India and China have been found to have ignored red flags, producing contaminated heart pills for years.
Strides is approved to make losartan, one of the drugs that is part of the wider recall, for the U.S. It acquired a unit of Vivmed Labs Ltd. in January that manufactures the drug, which was recalled in May.
Strides didn’t adequately investigate an unknown impurity found in an active ingredient used to make a drug, the name of which FDA redacted in the warning letter. Instead, Strides blamed the impurity on a substance it said it used to test the drug, swapped out that substance on a new sample to obtain a passing quality score, and used the ingredient that failed its testing to make finished drugs, according to the warning letter.
When drugmakers spot an impurity during testing, they’re supposed to attempt to identify what the potential contaminant is. Strides didn’t take that step, the FDA said.
The FDA’s letter to Strides is the latest in recent series of such communications to generic-drug manufacturers. Aurobindo Pharma Ltd. was warned by the agency last month for ignoring impurities in an active ingredient it produced. The name of the ingredient was redacted in the letter. Aurobindo, based in India, recalled contaminated valsartan in January and again in March.
©2019 Bloomberg L.P.