We are proud to share that Cormica’s Focus Laboratory in Allentown, Pennsylvania, has successfully completed an unannounced FDA inspection with no Form 483 observations issued.

The inspection took place last month and was a thorough review of our microbiology testing facility, which has seen significant developments since the last visit. These include the site relocation, the implementation of a new electronic Quality Management System (eQMS), and the introduction of a Laboratory Information Management System (LIMS).

The positive outcome is a strong endorsement of the quality systems, processes, and expertise upheld every day by the team at Focus. Led by our experts, and supported by colleagues across the Allentown site, the inspection result demonstrates our ongoing commitment to regulatory compliance and the highest standards of microbiology testing.

This achievement reinforces Cormica’s mission to improve patients’ lives by enabling our clients to bring safe and effective pharmaceutical and medical device products to market quickly and with confidence.

Cormica’s microbiology laboratories, including Focus in the US, provide a full suite of services to support sterility assurance, bioburden, endotoxin, antimicrobial efficacy, microbial identification, and more. We also offer advanced capabilities such as rapid sterility testing to help clients accelerate batch release without compromising compliance.