Labocont Draws Warning Letter for GMP Violations

The FDA warned a drugmaker in the Dominican Republic for significant good manufacturing practice violations including maintaining incomplete test data and faulty analytical methods.

The agency issued a warning letter to Labocont Industrial after it failed to provide acceptable responses to Form 483 observations following an inspection of the firm’s Santo Domingo facility in June.

Among other deficiencies, the investigator found the company manufactured drug and non-drug products and failed to adequately separate the production facilities, creating a risk of product contamination.