...show the influence of adverse FDA inspection and sample findings. A majority of recalls conducted recently have been prompted by FDA rather than manufacturer quality systems – a disturbing trend from the agency’s point of view. FDA compliance concerns are reflected, in particular, in a significant number of recalls during 2000 involving the potential for product contamination from faulty aseptic processing and the mishandling of beta-lactam products. Six contamination-related recalls drew a Class I rating as did nine involving products with unapproved claims or ingredients. Error and accident reports shed light on manufacturing problems biologic producers are having, but only a limited percentage result in recalls. [An eight-page tabulation of drug recalls listed in FDA "Enforcement Reports" during 2000 begins on p. 12.]
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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