Background

A recently registered 503B sterile outsourcing facility was facing significant FDA enforcement action following two critical FDA Form 483 observations. The FDA requested an immediate cessation of compounding activities and a full recall of all sterile compounded preparations due to a lack of sterility assurance. Regulatory Compliance Associates® Inc. (RCA) was engaged as an independent third-party cGMP expert to support the facility in navigating these regulatory challenges and restoring compliance.

RCA Approach

RCA’s team of experts guided client personnel in developing a comprehensive and effective response to the FDA Form 483 observations. A thorough baseline cGMP audit was conducted under the draft 503B regulations, followed by RCA’s support in managing subsequent FDA communications. Six months later, RCA led a certification audit to assess the facility’s progress. While additional observations were noted, RCA determined that no outstanding sterility assurance concerns remained.

RCA also prepared and trained facility staff for the follow-up FDA inspection. Despite the FDA deploying three specialized drug investigators, the facility received only minor, easily correctable Form 483 observations—all of which were fully addressed in the response, marking a significant regulatory turnaround for the client.

Results

Following a comprehensive review by the FDA’s Dallas District Office and the Center for Drug Evaluation and Research (CDER), the Agency formally issued a letter stating it had no objection to the firm resuming sterile drug compounding operations. With this clearance, Unique Pharmaceuticals became one of the first outsourcing facilities to successfully remediate FDA’s sterility assurance concerns related to pharmaceutical compounding. The facility also demonstrated full compliance with the new regulatory framework established under Section 503B of the Federal Food, Drug, and Cosmetic Act, setting a precedent for the industry.