FDA Warns Chinese Drug Testing Facility for Refusing Inspection

Regulatory NewsRegulatory News | 01 October 2019 |  By 

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent in August to China-based drug testing facility Shanghai Institute of Pharmaceutical Industry for refusing an inspection.

FDA had planned a surveillance and pre-approval inspection of the facility from 29 November to 4 December 2018, but the company told FDA’s China office in a written response that it was refusing the inspection.

"Under section 501(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(j), drugs are deemed adulterated if they are manufactured, processed, packed, or held in an establishment and the owner, operator, or agent delays, denies, limits, or refuses an inspection," FDA explains.

The firm is listed as a contract testing laboratory that provides active pharmaceutical ingredient (API) characterization and/or identification testing to support multiple abbreviated new drug applications (ANDAs), according to FDA.

More than a dozen other China-based drug manufacturers and other companies are included in FDA’s import alert list for foreign companies that have refused an inspection.

And in October 2014, FDA apublished final guidance explaining what constitutes delaying, denying, limiting or refusing a drug inspection.

“Access to these facilities is a critical aspect of protecting the health and safety of US citizens from unsafe products of foreign origin,” FDA says. “The refusal to permit inspection of a foreign facility or provide reasonable access to FDA's inspectional personnel, combined with other evidence, provides an appearance that the firm's products are manufactured, processed, or packed under insanitary conditions.”

Lupin Warning Letter

In addition, the agency sent a warning letter to India-based drugmaker Lupin for inadequate investigations into out-of-specification (OOS) assay results and insufficient process validation.

"FDA has cited similar CGMP violations at two other facilities in your company’s manufacturing network," FDA said, noting a November 2017 warning letter for Lupin facilities in Goa and Indore.

In response to the letter, FDA is seeking, among other information, a retrospective, independent review of all invalidated OOS (in-process and finished testing) results for all of its US drug products since 1 July 2016, "irrespective of whether each batch was ultimately shipped to the US". 

Warning Letter for Shanghai Institute of Pharmaceutical Industry

Warning Letter for Lupin Limited


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