The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has urged Pacira Pharmaceuticals’ cancer drug DepoCyte be recalled in certain EU countries, citing “manufacturing deficiencies” found at the company’s San Diego, Calif., facility.
The market correction follows a recent inspection of the plant by UK and French investigators that identified a lack of sterility assurance in the manufacturing process, the EMA said Friday.
While there is no evidence of risk to patients or microbial contamination of DepoCyte (cytarabine liposome injection) currently on the market, the EMA said, the “precautionary” recall will ensure patients are protected from potential harm.
Production and batch release of DepoCyte — approved in the U.S. for the intrathecal treatment of lymphomatous meningitis — are currently on hold, the EMA said. New batches of the drug will only be manufactured once all deficiencies have been resolved and a follow-up inspection indicates the San Diego site is compliant with good manufacturing practice requirements, the agency added.
While the company prepares for its next EU inspection, Pacira and other drugmakers must also keep an eye on ever-changing U.S. inspection policies.
Did you know that nearly all FDA inspectors are using laptops and tablets during their inspections, and many are asking for electronic copies of complaint or AER data and taking it back to their hotel rooms each evening to dissect and prepare additional questions for the next morning. Providing old or inaccurate data can quickly lead to problems.
These changes and many more are to be discussed at FDAnews’ Seventh Annual FDA Inspections Summit. Register today!