FDA flags persistent data-integrity lapses, insanitary conditions at Indian drug facilities

MUMBAI: The US Food and Drug Administration (FDA) continues to find serious data-integrity violations at Indian pharmaceutical manufacturing facilities and clinical research organisations, making information they submit for regulatory assessment unacceptable, a senior agency official said.

Eight years after FDA issued guidelines on data integrity, its inspectors continue to find violations that require the affected studies or tests to be repeated for reliable data, Constance Richard-Math, the agency’s deputy country director in India, told an industry gathering in Mumbai.

FDA’s routine or unannounced inspections have also uncovered cases in which truckloads of key documents relating to analytical testing, manufacturing procedures and storage were discarded, including records destroyed using paper shredders, Richard-Math said.


These violations, she warned, impedes building reliable and resilient supply chains.

FDA inspections continue to identify unacceptable and, in some cases, gross insanitary conditions in manufacturing facilities, she said, sharing pictures of dirty and dilapidated facilities.

Richard-Math urged drugmakers to look beyond their own facilities and scrutinise suppliers, vendors and other entities across the supply chain to ensure the safety of medicines.

“These may not be your facilities, but I would ask you to look beyond the walls of your own facilities: know your suppliers, know your vendors, know who is operating within your supply chain,” she said. “If you identify facilities operating at this level, whether they are vendors, contractors or even companies operating in your community, do not look the other way.”

She was speaking at the 25th anniversary of the Pharmaceutical Analysts Convention of Indian Drug Manufacturers Association.

During FY2025, the US FDA issued 39 OAI (official action indicated), which may include warning letters. While 149 inspections required voluntary action, 53 drew no regulatory action from the agency.

To build a robust culture of compliance, Richard-Math advised companies to detect warning signs early and resolve issues before they cause product failures, recalls, or shortages.

She stressed the need for drugmakers to ensure the reliability and quality of medicines supplied to patients in the US and elsewhere. She noted that there are over 600 US FDA approved manufacturing sites in India.

The FDA official further said she is delighted to see Indian drugmakers investing in building new manufacturing sites in the US.

A detailed survey-based white paper by Vector Consulting Group, ‘The compliance spiral in pharma manufacturing’, showed incident and investigation management processes can place a significant burden on manufacturing operations, affecting batch release timelines and leadership bandwidth.

The report noted that every manufacturing plant had a backlog of incidents awaiting a closure, with some taking up to six months to resolve. About 80% of respondents reported that open (or incomplete) investigations directly delayed batch release, while senior leaders reported spending as much as 27% of their time managing backlogs.

Another important finding showed human errors accounted for 56% of reported production incidents.

Operators were found to make, on an average, 120 entries in batch production records per shift, the report said. Also, 80% of supervisors were found to oversee five or more production lines per shift, potentially limiting the time available to verify work and identify problems early, it said.