FDA Warning Letter: Lack of Lab Data Integrity

The Indian manufacturer "Vega Life Sciences Private Limited" received a Warning Letter from the US-American FDA in June 2020.

This letter emphasized especially the findings in the area of solvent recovery. According to the FDA, the cleaning procedures of the solvent recovery equipment are not adequate to ensure the avoidance of contamination and carry over processes. In addition, according to the Warning Letter, the manufacturer has failed to create impurity profiles of the corresponding solvents and has also failed to investigate peaks of unknown impurities that have appeared in the chromatograms.

Furthermore, the FDA noted that the integrity of the data, mostly laboratory data integrity, could not be guaranteed. It was mentioned that the same username and password for the software of the GC instrument and the laboratory programme was used on every workstation and that no back-up of the computer system of the GC instrument was available. Likewise, according to the Warning Letter, there were no procedures for handling and storing audit trails. In addition, the missing raw data documentation of the GC analyses was found to be not in compliance with the cGMP requirements.

The complete list of the deficiencies and the recommendations and instructions of the FDA for the remediation of the deficiencies can be found in the Warning Letter for Vega Life Sciences Private Limited.