Daiichi-Sankyo Voluntarily Suspended API Shipments After Ranbaxy Import Ban
Daiichi-Sankyo said its Ranbaxy firm has voluntarily suspended shipments of active pharmaceutical ingredients (APIs) from the facility after receiving the US FDA Form 483 import ban.
The FDA has issued a recent inspection at the API plant Ranbaxy located at Toansa, Punjab in India. The inspection culminated in the firm’s receiving a Form 438 detailing several observations of good manufacturing practice (GMP) standards deviation. Ranbaxy was banned from supplying APIs to its New Jersey-based manufacturing site Ohm Laboratories which manufacture antibiotics, laxatives, antacids, and other medicines.
The FDA listed the following observations:
- Raw materials, intermediates, and finished API analytical results found to be suspect or failing specifications were not reported and retested until acceptable results were achieved.
- Samples were not analyzed in accordance to established lab test procedures.
- Computerized systems lacked established proper controls, a repeat observation from the previous inspection.
- Records were not completed during the same period.
- Lab samples were not properly controlled to avoid confusion.
- Adequate lab facilities were not maintained.
- Manufacturing equipment maintenance records were incomplete.
- Analytical instruments were not calibrated or maintained properly.
Ranbaxy Laboratories was acquired by Daiichi Sankyo in 2008 for $4.5 billion. The firm has previously settled for $500 million after pleading guilty to manufacturing and distributing adulterated drugs. Daiichi-Sankyo said it is considering manufacturing products from third party resources should the ban eventually cause shortages.
Carol Bennett, acting director of the Office of Compliance in the FDA Center for Drug Evaluation and Research said the federal watchdog was “taking swift action to prevent substandard quality products from reaching US customers.”
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