Tri-Med 483 Details Failures for Investigations, Impurities

The FDA handed Tri-Med Laboratories a Form 483 after finding the company’s analytical methods for Introl Solution and Infant’s Gas Drops were unable to identify or quantify impurities in finished dosage forms.

Further, the quality unit does not monitor impurities in finished dosage forms that were identified in vendor certificates of analyses, according to the June 21 form.

Another observation notes the quality unit investigated complaints of crystallization in a lot of tussin DM liquid but failed to analyze a sample from the suspect bottle after a consumer was hospitalized.
Drug GMP Report