The FDA has lashed out at India's Wockhardt, saying a plant in the U.S. was using the same questionable drug-testing procedures that led the agency to ban two of Wockhardt's Indian plants last year. The observation is one of a dozen cited in a Form 483 the FDA has issued to Wockhardt's Morton Grove Pharmaceuticals plant, a facility that has been helping prop up Wockhardt in the face of bans on the Indian plants.
Wockhardt acknowledged last week that it received the Form 483 for the plant about 40 miles northwest of Chicago but gave no details about the problems the FDA found. The FDA has now posted the document, showing it ran an inspection that went on for 17 days in January, February and March. The Form 483 criticizes the facility for unsanitary conditions and poor employee sanitation, but much of the report focuses on the "the continued uncontrolled use of 'trial' injections during chromatographic testing to release drug products and monitor stability of drug products after this practice was cited in warning letters issued to two other Wockhardt facilities."
The Indian plants were banned in part because the FDA said Wockhardt was testing "trial samples" of some drugs, then linking results from those to official samples that had not met test requirements. While the company told the FDA that the trial injections at the Morton Grove plant were for "informational use only," the FDA said it is unclear how the company used the data because it was not officially recorded and there was no audit trail. And, like at the Indian plants, Morton Grove allows unfettered access to computers by analysts, meaning that data could be tampered with by virtually anyone there.
Additionally, the documents said that the quality-control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred. It said out-of-spec problems were tracked only through emails and problems were not thoroughly investigated. It said one out-of-spec test was blamed on overheated suspension/agar, when other data showed no overheating problem occurred.
On the sanitation side of things, stagnant, moldy water was found standing in a drain of a basin below a hand dryer, while a worker was seen entering the manufacturing area without first washing and sanitizing his hands.
|Wockhardt Managing Director Murtaza Khorakiwala|
The U.S. plant reportedly generates about half of Wockhardt's U.S. sales and is key since the FDA last year banned plants in Chikalthana and Wajul for many of the same problems. The U.K. has also banned most of the drugs coming out of Wockhardt's plant in Chikalthana. The facility generated about $230 million a year in U.S. sales for Wockhardt before the ban. The U.S. has been the company's largest market and accounted for about 43% of its revenues. Wockhardt has already said the ban at its Waluj plant could cost it $100 million in lost revenues.
Wockhardt's managing director, Murtaza Khorakiwala, told analysts at a briefing last week that it did not view the inspection of the U.S. plant as being particularly "negative" and that the company had responded to all of the FDA's concerns.
- here's the Form 483 (PDF)