Warning Letter to API Contract Testing Lab Cites Data Misrepresentation to Customers

A recent FDA warning letter to US-based API contract testing lab Toxin Technologies highlights the agency’s ongoing concern with the communication between contractors and their customers.

In a strongly-worded warning letter to the Sarasota, Florida lab issued in February based on an August 2010 inspection, FDA asserted that Toxin Technology (TT) reported passing test results to a client firm when failing results were actually obtained, causing the “client’s API(s) to be adulterated.”

Inaccurate reporting of lab data has been high on the agency’s enforcement radar screen recently.

China-based Ningbo Smart Pharmaceuticals is among firms at which FDA investigators have uncovered the problem.  The API manufacturer received a warning letter in March citing the firm’s reporting of passing test results for organic volatile impurities on its certificates of analysis when no testing had been done on the referenced batches.  (IPQ “In the News” June 13).

In May, Indian API and generic drug dosage manufacturer Aurobindo received a warning letter in which the veracity of the firm’s environmental monitoring data in its contract manufacturing operation was brought into question (IPQ “In the News” June 13).

FDA’s multifaceted concerns with the integrity of the supply chain were key drivers for the recent reorganization of the Center for Drug Evaluation and Research (CDER) Office of Compliance and its establishment of a new “Office of Drug Security, Integrity & Recalls” (ODSIR) within the OC structure (IPQ “In the News” June 15).

[More analysis of the Toxin Technologies warning letter is provided for subscribers here.  Nonsubscribers may purchase the story for $95 by contacting Karen Bertani (Jonathan@ipq.org).  For subscription/license information, click here.]