The FDA inspection report Form 483 concerning J&J/McNeil's Puerto Rico facility, reported Tuesday, has one industry watcher renewing his call for the regulator to initiate a consent decree with the drug giant. Donald Riker, president and founder at On Point Advisors, says the decree in this case is necessary to enforce manufacturing and quality assurance regulations.
Riker says via email that he's not sure what triggers a consent decree, "but I think it has reached that point." Riker had first called for an FDA/McNeil consent decree in October on the OTC Product News website.
He's not alone. David Rosen, a consultant who previously logged 14 years with the FDA, tells CNN Money "it is disconcerting that these quality issues persist and that FDA has not taken further regulatory action." He notes that the regulator has stated its intention "to take a tough enforcement posture."
The inspection report, which counts eight manufacturing and quality-related items that do not comply with regulations, states "there is no assurance that the current laboratory controls are adequate to assure that drug products conform to the appropriate standards of identity, strength, quality and purity."
It also raises questions about whether Johnson & Johnson's comprehensive remediation plan filed in July is actually working.
Riker of On Point says the most recent 483 comments "continue to reflect a widespread systemic failure of a rogue manufacturing operation trying to fix itself." He suggests that McNeil's continuing quality-control issues may in part reflect errors in communicating the drugmaker's QA, regulatory and operations needs to contractors.
The FDA says it is reviewing the current findings and those of the prior inspection, as well as communications with McNeil, to decide on "possible enforcement action," according to CNN.
For its part, McNeil says it has responded to the 483 report and is working to address the most recent observations.
- here's the 483 inspection report
- see the CNN Money story