A number of companies have tried to keep FDA inspectors from getting a thorough look through their manufacturing plants, but none have gone to the extraordinary lengths of the Vikshara Trading & Investments plant in Gujarat, India, whose products the FDA banned over the deceptions.
Not only did the company put off an FDA inspection for months by claiming that its workers were on strike—even though it continued to manufacture products—but once inspectors got into the plant, they were left in the dark, literally. No lights were turned on, requiring inspectors to look around with flashlights.
The agency placed the plant on its import alert list in February and on Tuesday posted a recently issued warning letter that was short and sweet. It told Managing Director Tushar Patel that the site’s drugs are considered adulterated because they were manufactured, held or packaged at a facility where the owner delayed and/or limited an inspection.
Those delays began last summer after the FDA contacted the plant to set up a June 27 inspection and to make sure records would be available. Days ahead of the visit, the company delayed, telling the FDA that it workers had gone on strike and that they were blocking the entrance to the plant.
In July, the FDA was told that workers remained on strike, and in August the company sent the FDA “purported evidence of the strike” which included copies of employee resignation letters and a photograph of striking employees blocking the facility's entrance.
The problem, the FDA said, was that it learned that the company had “actively manufactured numerous products” between July 11 and August 9, the period of the alleged civil unrest that was supposed to have stopped production at the facility.
When inspectors finally got into the facility in October, they found more obstacles. Doors to the “vessel room and packaging and labeling storage areas were locked,” and lights were turned off throughout the plant.
Inspectors had to use flashlights to see in some areas. But even with limited visibility, they observed drug powder scattered throughout production areas, caked on the floor, and covering containers of finished products, as well as trash throughout the facility
Rounding out the plant’s failures was its refusal to provide inspectors with records. Managers indicated they would send them electronically later, but the warning letter says the agency has still not received any.
While the measures taken by Vikshara Trading & Investments to prevent an inspection were extraordinary, the plant is not the first to try to keep inspectors out, and the FDA is not the only regulatory agency to face such dodges.
Last year, the FDA warned Nippon Fine Chemical for the same kinds of shenanigans at its facility in Takasago City. At one point, NFC managers directed employees to form a human barrier by standing shoulder to shoulder to block access to areas of the laboratory and equipment used to analyze drugs destined for U.S. distribution.
Earlier this year, the FDA banned products from the Zhangqiu City, China, plant of API maker Jinan Jinda Pharmaceutical Chemistry because of a host of problems. Earlier, the European Medicines Agency had taken action against the company when inspectors from Italy reported that in a follow-up inspection they discovered raw supplies and finished products in a room in which the door had been screwed shut by employees. Inspectors "concluded there was a serious risk of data falsification" related to the ingredients in the room.