McNeil Consumer Healthcare’s recent recall of certain children’s products appears to be related to quality issues. And now FDA is widening its investigation. However, I read FDA’s inspection report a few days ago and learned there were some packaging-related observations included, too. It is unclear whether any of these would have been reason enough for a recall. But making note of these observations may serve to educate others in the industry.
For instance, FDA inspectors noted that “strict control is not exercised over labeling issued for use in drug product labeling operations.” Specifically, “labeling was not stored in a locked cage with limited access,” read the report.
The labeling observation intrigues me because strict accounting of label supplies should be part of a company’s error-prevention program as well as a brand security program. But how is this commonly achieved throughout the industry? Are there gaps that need to be addressed? By whom?
Also from the inspection report: “There is no written testing program designed to assess the stability characteristics of drug products.” Specifically, “stability samples collected off of the packaging line for lots . . . were pulled from the beginning of the packaging run. . . . Stability samples are not representative samples from the beginning, middle, and end of the fill run specifically for the three batches with super potent end sample fills.”
I have heard many questions from the industry about sampling, and this observation should serve to address some. Packagers wonder how to develop a statistically sound sampling method. FDA very clearly seems to state that sampling should involve the beginning, middle, and end of a run. Is this enough feedback from FDA–or is a more-specific plan required?