This is as much J&J's black-eye as it is New Merck's -- this venture's Lancaster, PA facility makes OTC versions of Merck prescription meds. Per CNN.com, this evening:
. . . .The facility is a operated by Johnson & Johnson-Merck Consumer Pharmaceuticals, a joint venture of J&J and drugmaker Merck formed to develop and market over-the-counter drugs derived from Merck's prescription medicines. The unit makes non-prescription products such as heartburn relievers Mylanta and Pepcid and multi-symptom relief drug Imodium. . . .
I'll keep a tab on this one -- Merck and J&J will have 30 calendar days to dispute the 483 findings -- but 483 deficiency letters usually end up requiring the company to undertake corrective action (with plans for the same be submitted to FDA for pre-approval), and then ongoing FDA monitoring to ensure the alleged violations have been adequately addressed and resolved.
