FDA inspectors observed several violations at a VistaPharm facility in Largo, Fla., including contaminated water used in manufacturing and batches of drugs that were not tested for impurities.
According to a Form 483, the company detected contaminants in purified water used to manufacture a variety of oral liquid drug products. In addition, the inspector observed that batches of various drugs were not appropriately tested for microorganisms.
The 483 further noted that VistaPharm lacked written procedures and a validated test method for sampling manufacturing equipment surfaces for microbial contamination. It also failed to validate its procedures for microbiological testing of purified water.
Inspectors said the company failed to establish adequate written procedures for maintaining, cleaning and sanitizing various pieces of equipment to ensure that it did not contaminate purified water. For example, heat exchangers were not properly cleaned and maintained, and transfer hoses were worn out and improperly stored.