The FDA has warned that a manufacturer of active pharmaceutical ingredients created a “severe hazard” by adopting substandard labeling and storage practices at plants in Arizona and Hong Kong. A warning letter, released on Feb. 12, came after one of the most notable findings by the FDA. The agency said that it encountered a container whose labels indicated the presence of an inactive ingredient, but that testing of the contents revealed a variety of different substances used to treat medical conditions.
The FDA wrote to CBSCHEM Ltd. that “the unacceptable practices that resulted in this mislabeling incident can pose a severe hazard to consumers.” Separately, the inspector complained that many records were incomplete, writing that 23 lots of active ingredients didn’t include batch numbers, manufacturing dates, expiration dates or retest dates. Inventory records were another source of concern, as they often omitted key information, making it impossible to identify and track the ingredients that CBSCHEM distributed, according to the letter, which stemmed from inspections in April and June.
The manufacturer responded to the FDA’s concerns on that point, but its reply was too vague for the agency to understand how supply chain integrity would be ensured, the letter said. CBSCHEM had not responded at press time for the issue. The company’s products have been the subject of import alerts in the past, including an October 2012 notice that involved antibiotic doxycycline and erectile dysfunction medicine sildenafil citrate, the active ingredient in Viagra.
The warning letter at one point suggested a near-total absence of quality assurance at CBSCHEM. What the FDA found is shocking. The agency wrote in the letter:
During the inspection, you stated you did not have a quality unit, provided no written documents describing the roles and responsibilities of a quality unit, and had no written procedures for quality activities.
To resolve the issues, regulators advised CBSCHEM management to conduct a “comprehensive evaluation” of their global operations and to retain a third-party expert on so-called good manufacturing practices. Until improvements are made, any drug maker using the company’s ingredients may see its applications rejected for new products, the FDA said.
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