FDA Regulatory Compliance Advisors, Inc.


Sterility Assurance


FDA-RCA’s wealth of experience evaluating sterile manufacturing processes and controls is at your company’s disposition to prevent the serious regulatory and financial hurdles that result from the distribution of possibly contaminated products to the market.

"Avoid Expensive Product Recalls"





“Combining science with regulatory knowledge for optimized systemic solutions.” ™ 

​Lack of sterility assurance and microbial contamination have been, and continue to be, major reasons for recalls of drug products.

Because microbial contamination in drug products represents such a high risk for patients, FDA takes swift enforcement actions against pharmaceutical companies that fail to implement the necessary controls to prevent it.    

Ensuring the sterility of pharmaceutical products requires the implementation of GMP-compliant procedures and practices, and suitable facility design and equipment. 

​The variety of processes used to manufacture sterile products require validation and control, since each process could introduce an error that ultimately could lead to the distribution of a contaminated product.