Biotech Values

[poorgradstudent]

At least for NDAs, the manufacturing inspection is a mandatory part of the complete FDA review. So I agree with previous comments that the inspection is necessary for a Teva approval but not sufficient.

Also, if I'm not mistaken, Teva has manufacturing facilities as part of their empire. In that respect, it's not really surprising that they've had a successful appraisal of their plant(s).

If anyone wants to focus on a sneaky angle, you could wonder if Teva said "yes, we've been inspected" because their facilities are regularly inspected. But were they inspected pursuant to the enox filing? The only reason I only bring up a silly little thing like this is if Teva is the owner of the manufacturing (rather than going through a contractor), it would seem redundant / wasteful for the FDA to constantly show up at Teva's facility for the company's own filings.

Just some pointless speculation...