Tijuana Drugmaker Warned for Lax Investigations

The FDA hit a Tijuana drug manufacturer with a warning letter for shoddy investigations into microbiological contamination and other serious violations observed during an agency inspection.

The agency took Baja Fur to task for failing to fully investigate contamination that led to the rejection of a number of batches of an OTC drug product.

The company recorded the out-of-specification microbiological contamination in its annual product review, but it failed to detail its investigation into the source of the contamination and the actions taken for distributed products that may have been impacted.