The FDA issued a warning letter to Hangzhou Karic Commodities and placed it on an import alert after an inspection of its Hangzhou, Zhejiang facility revealed numerous violations, including a failure to test batches for conformity prior to release.
The March inspection of the firm’s contract manufacturing plant found CGMP violations related to product testing. For example, the company failed to check that each batch of drug product conformed to specifications for active ingredient identity and strength.
The facility also failed to test the quality attributes of inactive ingredients and incoming raw materials, instead using certificates of analysis from suppliers that were not evaluated for reliability.
Batch failures were not fully investigated, the agency noted. For instance, the firm launched an investigation after it observed the primary packaging tube of a reserve sample had changed color. It determined that the supplier had sent the wrong primary packaging material, but failed to evaluate what effect that had on the drug.
In addition, the company did not validate its drug manufacturing processes, failing to conduct process performance qualification studies. It also had no program for monitoring process controls to ensure manufacturing stability and consistent drug quality.
On July 16, the FDA placed the firm on an import alert for detention of its products at U.S. ports.