And so the sorry saga of Johnson & Johnson manufacturing problems continues. This time, though, the FDA has tagged the health care giant for problems at its Cordis stent facility in San German, Puerto Rico. Over a two-year period, the plant failed to follow up a protocol failure and to ensure devices conformed to specifications (read the letterhere).
To date, manufacturing issues plaguing J&J involved screw ups at McNeil Consumer Healthcare plants that make over-the-counter meds. In fact, one plant in Fort Washington, Pa., which is where McNeil offices are based, is now shuttered and being re-tooled. However, another is located in Las Piedras , Puerto Rico, further indicating J&J units are unable to rectify problems near and far.
The manufacturing problems at the Las Piedras facility caused the FDA to issue two separate 483 enforcement reports, prompting one securities analyst to repeatedly brace his clients for the possibility that J&J may encounter a consent decree (read this) and House Republicans to lean on the FDA to more closely track manufacturing plants in Puerto Rico, in general (look here).
Last summer, J&J ceo Bill Weldon placed manufacturing and quality strategy under the oversight of corporate vice president Ajit Shetty, who reports directly to Bill. Perhaps the move will yield some dividends in the future. For now, though, the ongoing disclosures enlargen the stained legacy of seemingly ceaseless product recalls and production gaffes that Weldon will leave behind.