Regulatory Focus™ > News Articles > FDA Finds 'Significant' Problems at API Manufacturer

FDA Finds 'Significant' Problems at API Manufacturer

Posted 12 February 2014 | By Alexander Gaffney, RAC

Two facilities maintained and run by a manufacturer of active pharmaceutical ingredients (API) exhibited serious violations of current good manufacturing practices (CGMPs), the US Food and Drug Administration (FDA) said in a Warning Letter issued this week.

The API manufacturer, CBS Chem, was subject to two separate inspections in 2013, one for its facility in Tempe, AZ and another for its Tuen Min, Hong Kong facility.


While FDA inspectors alleged that both facilities had problems, those alleged to have taken place at the Tempe facility were particularly jarring.

In one instance reported in the Warning Letter, an FDA inspector tested a container that was labeled as having a specific excipient. However, FDA's testing determined that the container was full of a mix of at least five different ingredients, and apparently active ingredients, as FDA said they were used to treat specific unspecified diseases.

"The unacceptable practices that resulted in this mislabeling incident can pose a severe hazard to consumers," FDA wrote.

The same facility was also chided for failing to implement a system by which it could confirm the identity of APIs received there.

"[Y]our firm failed to provide basic documents that must be retained including those with the identity and address of the original manufacturer (e.g., COAs, other records with critical information regarding the ingredients)," FDA wrote, adding that the approval of the quality unit personnel was also missing.

Hong Kong

Similar problems were found at CBS Chem's Hong Kong facility, FDA said. The firm was found to have maintained incomplete records for its APIs, failed to transfer quality and regulatory information to its customers and improperly maintained its packaging and holding areas to avoid mix-ups.

In addition, the company reportedly failed to have a quality unit responsible for assuring product quality or reviewing and approving CGMP documents.

FDA recommended that the company hire the services of a third-party consultant to bring it up to federal production standards.


Warning Letter


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