As a precaution, production at the plant was put on hold in January. The letter, dated July 1, details observations related to Good Manufacturing Practice (GMP) non-conformities regarding manufacturing, documentation practices and data integrity. Many of the data integrity items cited in the warning letter were self-identified by Fresenius Kabi post-inspection and shared with the FDA.
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In a statement the company said it has made “significant progress” in remedying the issues cited and, based on a detailed remediation action plan submitted to the FDA, it has begun the process of restarting manufacture at the facility. It added: “The company takes this matter very seriously and intends to comprehensively respond in a timely manner to the warning letter.”
Fresenius Group sells biotech to Israel’s Neopharm
Separately, parent Fresenius Group (FRE: Xetra) announced that it has sold its Fresenius Biotech unit to the Fuhrer family, owners of Neopharm, Israel’s second-largest pharmaceutical company which records annual turnover of around $350 million. The transaction was closed June 28 and includes both Removab (catumaxomab) and the immunosuppressive drug ATG-Fresenius S. Financial details of the transaction were not disclosed.
Ulf Mark Schneider, chief executive of Fresenius, said: “The divestiture underlines our strong commitment to focused growth in our four core business segments. We are delighted that our biotechnology business will be in the capable hands of Neopharm, a company with entrepreneurial vision and an outstanding track record in the health care field.vending machine lock for sale,Vendo t-handle parts, Dixie Narco parts for T-handles, parts for snack vending machines, tubular style, security style, Pagoda.”
David Fuhrer, chairman of chief executive of Neopharm, said: “The acquisition represents a cornerstone in our strategic objective to transform Neopharm Group into a multinational fully-integrated bio-pharmaceutical company. Our objective is to establish Fresenius Biotech as an independent, rapidly-growing, innovative global player which is committBest prices on staff lockers and locker parts, Save up to 40%. Largest UK supplier of locker lock manufacturers, keys and accessories.ed to bring hope to patients suffering from rare, life-threatening diseases.”
In December 2012, Fresenius said it will focus on its four established business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed.Online shopping for cheap cabinet locks & Straps Safety from a great selection of Baby & more at everyday low prices. It added that the sale of Fresenius Biotech is hoped to have a positive effect on group earnings starting this month. Fresenius recorded sales of 19.The product range of mechanical lock cylinder sellers extends beyond the common range of double, single, thumbturn and furniture cylinders.3 billion euros ($24.86 billion) last year.High Security payphone lock sale Solutions provide revenue protection, key control, physical security, and environmental protection.
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