Discarded Batch Documentation again found during Inspection

Unfortunately, it happens again and again that pharmaceutical companies do not archive their documentation but discard it, a violation of basic GMP requirements. Occasionally this is discovered during inspections. The number of unreported cases is certainly higher. Now Unexo Lifesciences, an Indian manufacturer, has been caught by the FDA.

For example, torn batch production records were found in plastic bags on the rooftop. These included missing batch production records, which allegedly could not be found during an FDA inspection. Furthermore, duplicate, incomplete batch records with the same batch numbers and issuance dates as the batch records presented during the inspection were found among the torn records. Batch records were "retrospectively prepared" in order to present them to the inspectors.

In the Warning Letter that has now been issued, the FDA is ultimately concerned about the validity of the company's reconciled records. The FDA emphasises that "complete and accurate batch production and control records must be contemporaneously documented to ensure that manufacturing processes are consistently followed and reproducible. Additionally, incomplete manufacturing records deprive you of the ability to adequately investigate deviations."

Unfortunately, this was not all: laboratory records were incomplete, raw data was missing and data could be manipulated retrospectively. Nevertheless, batches were released.