India-based drugmaker Dr. Reddy’s Laboratories has received a warning letter in which the US Food and Drug Administration (FDA) cites incidents of data manipulation, and potential contamination issues. The most worrying discovery made by the agency, was that Dr. Reddy’s was using an undeclared laboratory to test batches of drugs which were then shipped to the US despite multiple failures for issues with impurities.
This most recent warning letter is hardly the first issued to Dr. Reddy’s. The warning letter was sent to the company earlier this month, detailing infractions made at three of the company’s manufacturing facilities in India.
Though Dr. Reddy’s commented that they were “actively engaged” with the agency in order to resolve the issues, the warning letter suggests that the company has still not fixed all of the problems revealed in the inspection. The most glaring breach of regulations was identified when an employee of Dr. Reddy’s disclosed the existence of an “uncontrolled Custom QC laboratory” the company had been using since 2012 to test active pharmaceutical ingredients (API) to be shipped to the US.
The FDA uncovered evidence that the company was testing APIs for impurities multiple times, without ever recording failed tests. Instead, Dr. Reddy’s opted to only record data from batches that passed QC tests.
Along with the issues identified at the plant in Srikakulam, inspectors also noted that an API plant in Miryalaguda was employing supervisors who were not protecting records and equipment from being manipulated by employees. Because of this lack of oversight, workers were changing and destroying select records.
According to the FDA warning letter, Dr. Reddy’s explained the lack of data protection on an “unknown individual.” The warning letter said, “This unknown individual performed injections and deletions without the analyst’s knowledge.”
The third plant mentioned in the FDA-issued warning letter, was the Dr. Reddy’s Oncology Formulation facility in Duvvada. The FDA noted the potential for sample contamination based on the way workers were handling vials.
The government agency also found that the Duvvada plant lacked any standards to ensure that the pharmaceuticals manufactured there met the specifications for purity, quality and strength. Dr. Reddy’s joins a number of other Indian pharmaceutical manufacturers – including Sun Pharmaceutical, Ranbaxy Laboratories and Wockhardt – who have recently been served with FDA warning letters and plant bans.
- Dr. Reddy’s blasted in warning letter for hiding existence of testing lab from FDA – http://www.fiercepharma.com/story/dr-reddys-blasted-warning-letter-hiding-existence-testing-lab-fda/2015-11-24
- Dr. Reddy’s Laboratories Limited 11/5/15 – http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm473604.htm