ForMor contests a warning letter from FDA stating that as an own-label distributor, the firm is subject to both packager and labeler GMP requirements. The firm says it is only a “holder” of finished products and FDA bases its warning on the GMP rule preamble, not the actual rule.

ForMor contests a warning letter from FDA stating that as an own-label distributor, the firm is subject to both packager and labeler GMP requirements. The firm says it is only a “holder” of finished products and FDA bases its warning on the GMP rule preamble, not the actual rule.

The dealmaking column is a survey of recent transactions, including strategic alliances, mergers & acquisitions, and financings, in the life sciences industries. Deals are listed by the following industry sectors: in vitro diagnostics, pharmaceuticals, medical devices, and research/analytical instrumentation and reagents. All transactions are excerpted from Windhover's Strategic Transactions database, providing comprehensive transaction coverage from 1991 to the present.