There's been another quality "oops" at Johnson & Johnson, but this time in the device category. The company announced earlier this week that it's recalling 100,000 boxes of 1-Day Acuvue contact lenses sold in Asia and Europe because of a manufacturing problem. Some users reported pain and stinging after putting in their lenses.
The company says that the manufacturing line problem has already been fixed. But the announcement remains an unfortunate counterpoint to the news reported last week of a QA/QC rebuilding effort that re-establishes a corporate-wide quality arm at J&J. That announcement had seemingly re-established a modicum of credibility to the corporate giant among its drugmaker peers, regulators and customers.
Such news would barely get a notice under ordinary circumstances. But when it's a big gun like J&J, and both the company and the FDA have been called before Congress to explain recent massive product recalls, a QC hierarchy change gets lots of attention.
That's likely just what the FDA had hoped for in its high-visibility dealings with J&J over the product recalls and GMP violation warnings, as the regulator attempts to spread the word among drug (and device and food) providers that Sheriff Hamburg means business.
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