J&J/McNeil continues to set a blistering pace among pharma manufacturers for GMP violation and repeat violation citations. In a Form 483 inspection report curiously posted by the FDA over the long holiday weekend, the regulator notes eight observations following a late September through early November visit to McNeil's Puerto Rico plant.
That plant's most recent previous inspection was just eight months earlier--in late January of this year--and also yielded a Form 483.
Jim Prutow, a partner in PRTM's healthcare practice, notes that some of the eight observations in the current Form 483 relate to problems that precede the company's submission to the FDA in July of a comprehensive remediation action plan, but that some are from later and even reference the plan. "For some of these things to be found during a second inspection is concerning," he says.
"So what's next?" asks Prutow. "FDA has said no more repeat warning letters. And in this inspection report the agency is specific in mentioning repeat violations." Observations 1 and 8, concerning a lack of written quality control procedures and shortcomings in written procedures for cleaning and maintenance, are both "recurrent observations."
Yet despite FDA pronouncements, a warning letter might be the next logical step, depending on how McNeil responds to the inspection report.
Another possibility, says Prutow, is the FDA will be satisfied by McNeil's plan as represented in its response. The New York Times reports that a McNeil spokesperson says the company has responded in detail to the FDA's concerns.
And another possibility is that, by conducting the inspection and issuing the observations, the FDA is laying the groundwork for further action it may deem necessary. For example, a recent inspection is one prerequisite of the agency's entering into a consent decree, Prutow says.
- here's the redacted Form 483 from the most recent inspection
- and here's the 483 from the early 2010 inspection
- see the NYT article