FDA Warning Letter addressed to a Manufacturer of Medicinal Products in Hong Kong

Recommendation

27/28 June 2023
Heidelberg, Germany

Dissolution Testing
Development / Quality Control and in vivo Relevance

The FDA sent a warning letter to a manufacturer of medicinal products in Hong Kong on 15 December 2015. This warning letter criticises among others the following points which occurred during an FDA inspection taking place in July 2015:

• In the finished medicinal products identity and strength of the active ingredient were not tested. 
• The identity of active ingredients and excipients from various suppliers was not verified. 
• There was no data available on the control of stability. 
• There didn't exist written procedures for production and process controls, including validation protocols and reports. 
• There were neither written SOPs for the responsibilities nor for the review of out-of-specification results or for the handling of customer complaints. 
• Evidence of regular calibration was missing for the scale in the production area. 
• Multiple batches were released, despite a variety of deviations.

The FDA has not received a response from the firm concerning CAPA measures. As a result, the firm was now placed on Import Alert with immediate effect.

You will find more details in the complete FDA Warning Letter to Chan Yat Hing Medicines Factory.