India’s Wockhardt, which has now amassed a record seven FDA warning letters for plants on three continents, appears to be reaching a breaking point with the agency.
The FDA, in its latest warning letter posted Tuesday, savaged the Indian company for repeated and persistent manufacturing failings across its manufacturing network and ordered it to do a top-to-bottom rework of its production procedures at all of its FDA-approved facilities.
The warning letter said that in multiple meetings, Wockhardt official “have repeatedly discussed and promised corporate-wide corrective actions.” Yet, the FDA said, when its investigators return to or inspect another Wockhardt plant, they find the company persistently making the same mistakes.
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“These repeated failures at multiple sites demonstrate your company’s inadequate oversight and control over the manufacture of drugs,” the FDA said.
That is despite the fact that the FDA has been pointing to repeat problems at Wockhardt plants for more than four years and after the company claimed it had brought in consultants to help it address the FDA’s concerns.
The dressing-down by the FDA came in its latest warning letter, this one for Wockhardt’s Morton Grove Pharmaceuticals site in Illinois. The site north of Chicago received a Form 483 in 2014 that was issued after an FDA inspection that went on for 17 days.
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Among the issues outlined in the warning letter, the FDA said Wockhardt didn’t adequately investigate out-of-spec batches, and in a number of cases conducted investigations as “internal audits” to circumvent the quality unit and its procedures.
When the FDA pointed out one investigation into failed stability tests for two different batches of triamcinolone acetonide lotion remained open for more than five months, the company said the investigation “fell through the cracks.”
That and other responses fell far short of FDA expectations, and the company has been given a long and detailed list of what it needs to do to bring its plants in the U.S. and elsewhere to FDA standards.
RELATED: FDA issues untitled letter to Wockhardt's new sterile injectables plant
In the midst of the all of the revamping to return the seven plants to FDA expectations, the Indian company has been trying to get a new sterile injectables plant in Shendra, Aurangabad, approved so it can sell products in the U.S., where its business has been devastated by FDA regulatory actions. Instead, the FDA in January issued that plant an untitled letter for many of the same shortcomings found at its other plants.