FDA Warning Letter due to Non-Compliance with Specifications

Recommendation

24/25 April 2024

QC Compliance Manager - Live Online Training

This FDA Warning Letter issued to Indian drug manufacturer Kim Chemicals Private Ltd. on 16 October, 2017, is based on an FDA inspection conducted in July 2017.

The FDA criticised that not all drug products and the active substances they contained had been tested for compliance with their specifications before release. Some batches were distributed to the USA even though the active ingredient content was out of specification (OOS). They had simply copied values from old certificates of analysis to the new batches'  certificates of analysis.

In quality control, there were no written procedures in the form of SOPs for a number of critical processes. This included requirements for:

• Complaint handling
• Recalls
• Investigation of OOS results
• Deviation investigation
• Returns
• Stability

Furthermore, no data could be supplied to verify the values listed in the analysis certificates.

The performed tests had been noted down in a piece of paper and then transferred to the certificate of analysis, while the piece of paper was simply discarded. Also, there were no records on how the calculation had been performed.

The FDA therefore concluded that the company's quality management system is not fit to verify the accuracy and integrity of data.

Source: FDA Warning Letter to Kim Chemicals Private Ltd.