Regulatory Focus™ > News Articles > Warning Letter Hits Pharmaceutical Company for Alleged Failure to Test Quality of 'Any Batch'

Warning Letter Hits Pharmaceutical Company for Alleged Failure to Test Quality of 'Any Batch'

Posted 17 April 2013 | By Alexander Gaffney, RAC

A warning letter issued on 1 April 2013 to a Japanese pharmaceutical manufacturer-the second in as many weeks-alleges that the company's manufacturing operations were significantly deficient because they failed to meet basic regulatory requirements.

The company, Kanebo Cosmetics of Kanagawa, Japan, is a manufacturer of finished pharmaceuticals and cosmetic products-not always a mutual distinction, as in the case of sunscreen products, which the company manufactures.

Alleged Deficiencies

A September 2012 inspection of Kanebo's manufacturing facility by FDA's investigators found that the company had failed to meet a number of current good manufacturing practice (CGMP) regulations, including failure to determine the purity and strength of the active ingredients present in some over-the-counter (OTC) products that the company has since distributed in the US.

Unlike many warning letters, in which this general warning applies to a limited number of batches or occasions, FDA said that the company had failed to do this for "any batch" of the same OTC product. Regulators did not identify the OTC product by name in the letter except to note that it is "currently in the US market" and that it contains an active pharmaceutical ingredient.

In another alleged instance, the company was said to have not implemented a thorough testing program to assess the drug products' stability, used to determine adequate storage conditions and expiration dates. Again, the company was alleged not to have conducted any testing-in this case long-term stability studies-on OTC drug products distributed to the US market.

In still other alleged examples, the company did not test active pharmaceutical ingredients received from a supplier to determine their strength, purity, and quality. Companies are required to do so to ensure that their products use the appropriate starting materials, and not a deficient or counterfeit product.

FDA's inspectors reiterated that their concerns were "serious," and recommended that the company engage the assistance of a third-party to bring its operations into compliance with US regulations. The company's products will be refused admission into the US until those deficiencies are corrected, FDA said. 


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