Asian regulators take issue with J&J facilities
pharmafile | May 7, 2013 | News story | Manufacturing and Production |Â Â India, J&J, JJ, Korea, inspectionÂ
Johnson & Johnson’s manufacturing network is under yet more scrutiny following regulatory actions by authorities in India and South Korea.
Officials from Maharashtra state in India revoked a manufacturing license for a personal care products facility operated by J&J near Mumbai, after an inspection revealed the firm was using an unapproved process for sterilising baby powder products.
The company made use of ethylene oxide instead of steam as a sterilising agent for a limited production run but failed to carry out tests to make sure no residue was left in the resulting product, according to Reuters. J&J insists the process is safe and widely used in the medical devices sector, and says it has appealed the shutdown decision.
Meanwhile, the longstanding manufacturing problems affecting J&J’s over-the-counter (OTC) medicines division have resurfaced, with the news that South Korea’s Ministry of Food and Drug Safety (MFDS) has suspended production at a plant in the country, says a Korea Times report.
The agency made the move after ordering a recall of a paediatric Tylenol (acetaminophen) product because it contained excess levels of active ingredient.
The new regulatory actions are an unwelcome setback for J&J just as it seems to be getting a grip on quality control problems that have dogged plants in the US and Puerto Rico.
Just last month, J&J said it was moving towards a sustained recovery in its consumer health business, which has been affected by recalls of millions of product units causing shortages since 2010, and still has three facilities operating under an FDA consent decree implemented the following year.
Chief financial officer Dominic Caruso said on the firm’s first-quarter conference call that the company now expects to have 75% of the affected brands back on the market by the end of the year.
Phil Taylor
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