>>Who's suggested connection?
Moness Crespi Hardt write-up:
Then, two weeks ago, Teva disclosed that it had received an FDA Warning Letter regarding contamination issues at its Jerusalem oral solid dosage plant. While this plant is not involved in manufacturing generic Lovenox, the Agency wrote, “Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with [Current Good Manufacturing Practice regulations], FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer.”
There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)