Warning Letter due to Non-Compliance with Specifications

Recommendation

12-14 December 2023

Stability by Design - Live Online Training
- Stability Testing in Product Design and Method Development- Focus mainly on small-molecule APIs and drug products

This FDA Warning Letter issued to Chinese pharmaceutical manufacturer Shanwei Honghui Daily Appliance Co. Ltd. in China from 05 December, 2017, is based on an FDA inspection from July/August 2017.

The company failed to check all batches of the manufactured drug product for compliance with the specifications.

It became apparent during the inspection that incoming active pharmaceutical ingredients and excipients were not tested for identity upon entry. The company instead relied on the supplier's certificates of analysis. However, those had not been qualified.

Shanwei Honghui had not verified the analysis results from the supplier's certificates. There was no adequate validation in the form of checking the supplier's analysis results in regular intervals.

In their response to the FDA on 23 August, 2017, Shanwei Honghui named a lack of experience with the FDA as a reason for this. The response is described as inadequate and not detailed enough in the FDA warning letter.

As a consequence, the FDA now placed the company on Import Alert.

Further details are available in the complete FDA Warning Letter issued to Shanwei Honghui Daily Appliance Co. Ltd.