- The Food and Drug Administration has had it with Vikshara Trading & Investments Ltd., placing the Indian drugmaker on its import alert list and issuing a warning letter after the company staged a worker's strike to duck out of an inspection last year.
- In April 2016, Vikshara Trading told the FDA its staff had gone on strike and blocked the entrance to the Gujarat-based facility, leading the FDA to cancel its planned visit. Later that summer, Vikshara Trading sent the regulator photos of protests and resignation letters purporting to be from employees.
- But it was all apparently a ruse. The FDA found evidence the company was still manufacturing drug products during the time workers were supposedly on strike.
The FDA has increased its inspections of foreign manufacturing facilities that ship to the U.S., particularly in the large export markets of India and China. The stepped-up regulatory oversight has caused its fair share of headaches for manufacturers out of compliance with the agency's standards.
Sun Pharma, for instance, has struggled to get its Halol manufacturing plant up to code, hurting its ability to export products to U.S markets — a key growth region for the generic drugmaker.
But most firms don't concoct elaborate schemes to derail the FDA's inspections. Vikshara Trading's sham strike delayed the FDA's inspection by nearly four months, all the while producing new batches of drugs.
"Despite your assertions that your employees were on strike, FDA obtained evidence that your firm actively manufactured numerous products, including at least [redacted] batches of drugs, between July 11, 2016 and August 9, 2016," the FDA wrote in its warning letter.
When the FDA's inspector was able to visit Vikshara's facility in October, doors were locked and the facility lights were shut off. The investigator searched the site by flashlight, finding powder scattered throughout production areas including on finished drug products.
Needless to say, the FDA wasn't thrilled and in February placed Vikshara on its Import Alert 66-40 and Import Alert 99-32 — meaning any imports from the company could be detained without any physical examination.
The drugmaker has the standard 15 working days to respond to the FDA's warning letter.