- The Food and Drug Administration slammed Indian drugmaker Wockhardt for repeated GMP violations across seven manufacturing facilities, sharply criticizing the company's "inadequate oversight and control" over its production processes.
- In a recently published warning letter flagging new concerns at an Illinois site, the regulator demanded Wockhardt undertake a review of its global manufacturing operations to ensure company-wide compliance with FDA standards.
- Issuing such a broad critique is a relatively rare occurrence, but the FDA's patience was tested by Wockhardt's slow response to a steady drip of warnings issued over the past four years. Promised corrective actions never materialized, the FDA wrote, and similar violations were found again and again across sites.
The FDA's concern over Wockhardt's recalcitrance was tucked into a warning letter sent to Wockhardt's Morton Grove facility in Illinois, which had been inspected in January 2016.
According to the warning letter, the Morton Grove site failed to properly review out-of-specification results and deliberately conducted investigations outside of its quality-control unit in order to sidestep written procedures.
In 2015, for example, two batches of triamcinolone acetonide lotion failed stability testing due to excipients used in the manufacturing process. Without performing a hazard evaluation, the facility continued to distribute other batches of the product while the investigation remained open for 5 months. Answering questions during the January inspection, site management told the FDA that the investigation "fell through the cracks."
The regulator also identified several issues with the site's production of fluticasone propionate nasal spray (Flonase).
Wockhardt's troubles don't stop there. Only a month before the most recent warning, it had received an untitled letter from the FDA citing deficiencies at another plant in Shendra, India.
All told, three of the seven plants warned since 2013 were flagged for poor aseptic practices while data manipulation was cited at five facilities (including one of three cited for its aseptic practices).
In a notice to Indian stock exchanges at the beginning of March, Wockhardt said it had "initiated appropriate measures" over the past several months to respond to the FDA.