The Form 483 followed the US FDA’s first China inspection under the HSP (Human Subject Protection)/BIMO (bioresearch monitoring program) initiative.
The details of the violations were not released but Matt Harrington, a spokesperson for Frontage, told Outsourcing-Pharma.com that the issues cited “are minor” and “will be sorted without a problem.”
Frontage hosted the FDA inspectors for two weeks to inspect the bioanalytical labs in support of one ANDA (abbreviated new drug application) and one NDA (new drug application). The company’s clinical research centre in Zhengzhou also hosted agency officials for a one-week inspection of a bioequivalence study in an ANDA and that did not result in any Form 483 notices being issued.
“It was a positive experience to have the FDA come in and recognize us as worthy of this inspection because it’s major to have this type of quality review,” Harrington said. He also noted that clients will likely value the inspection as proof that the CRO has a reputation for quality.
The inspections were conducted from late February to early March, according to Frontage.
FDA’s HSP/BIMO Initiative
The inspections of the two facilities was the first time that the FDA has completed an inspection in China under its combined clinical trial and bioresearch monitoring program, known as HSP/BIMO, Harrington said.
The FDA established the program to help protect the rights, safety, and welfare of clinical trial subjects; determine the accuracy and reliability of clinical trial data submitted; and to assess compliance with its clinical trial regulations, including those for informed consent and ethical review.
Under the program, the FDA’s CDER (Center for Drug Evaluation and Research) is piloting a way to more rapidly identify clinical sites for inspections related to NDAs. CDER is also developing similar risk-based models to prioritize CRO, IRB (Institutional Review Board) and clinical and analytical facilities (related to generic drug applications) sites for inspection.
Harrington added that Frontage’s other Chinese facilities have not been discussed as being inspected as part of the program.
“We are pleased that the FDA has approved of our efforts to bring industry leading drug development practices to China,” Dr. Song Li, chairman and CEO of Frontage, said. “As more pharmaceutical companies seek to expand business in China, they are looking for a company that can provide clinical and bioanalytical research services with globally accepted quality standards. Frontage is the first company to offer such a combination in China that has been inspected by the FDA.”