Chinese API Manufacturer Draws FDA Warning
The FDA placed Sichuan-based drugmaker Sichuan Friendly on an import alert after an October inspection of its facility in Neijiang City revealed stability and manufacturing issues with active pharmaceutical ingredients shipped to the U.S.
The agency found that the firm did not properly conduct residual solvent testing of its APIs distributed to the U.S. and it failed to test for residual solvent levels in intermediate or finished API batches to determine whether the results were within acceptable levels.
The firm also manufactured certain APIs on shared equipment, creating a risk of potential adverse effects due to the firm’s use of a class 2 solvent with an inherent toxicity that must be controlled to protect products.
The company also could not provide data to support a certain API’s shelf-life as labelled under the U.S. Pharmacopeia. The agency criticized the firm for not committing to develop a complete stability program for its API or demonstrate that its methods meet the claim of the USP label. It also did not demonstrate that its test methods are stability-indicating.
In addition, the firm did not demonstrate that its cleaning procedures for non-dedicated production equipment properly prevented cross-contamination by conducting adequate cleaning validation studies. It used multiple solvents, both class 2 and 3, in manufacturing, but its validation did not check for potential carryover of residual solvents between drug products.
It also manufactured an API on certain equipment but failed to perform cleaning validation on the remaining pieces of shared equipment to prevent cross-contamination of different APIs and intermediates.