Another FDA Warning Letter with Focus on "Data Integrity"

A Warning Letter issued by the US Food & Drug Administration (FDA) to an Indian API manufacturer on 13 July 2015 shows again a clear focus on the missing integrity of data. Specifically, the following issues are addressed:

1. Activities were not recorded at the time they were carried out and original data were deleted:

Entries in the manufacturing protocols were made only days after the relevant activities had been conducted. Further, batches were released before all results were available.

In particular the use of "rough notes" was criticised as these original data were completely destroyed after transfer in the batch records.

2. Due to unauthorised access to data systems, data could be modified or deleted:

Specifically HPLC, GC, and Karl Fischer Titrators were concerned. For instance, for the GC instrument multiple copies of raw data were found in the waste. And there was no password regulation for the data systems of HPLC and GC equipment, and there were no audit trail functions either.

3. There were no training protocols for the cGMP training of employees.

Altogether there were great concerns about the authenticity and reliability of the data produced in this company. Thus the FDA requested a comprehensive CAPA plan within 15 working days upon receipt of the Warning Letter.

For detailed information please see the full Mahendra Chemicals Warning Letter.

Source: FDA, United States