Sweetgrass GxP is the exclusive partner of Letco Medical to provide Regulatory Solutions for compounding pharmacies. To Learn more about the Regulatory Solutions provided click on the button below or the Regulatory Solutions Logo.
If you are not sure, let Sweetgrass GxP work with you and your team to determine where gaps may exist and develop a comprehensive action plan to address them. Allow us to develop appropriate Standard Operating Procedures, provide required training to staff, perform risk assessments where appropriate, and assist in the design and development of appropriate containment solutions to ensure compliance.
USP Chapters <795> and <797> are both currently under revision. Let Sweetgrass GxP guide you on the differences between the current and proposed chapters, assist in developing an action plan to address any gaps. In addition, it is expected that significant training will be required to support the changes in both USP <795> and <797>. Sweetgrass GxP can design, develop, and administer in-depth and interactive training to you and your staff.
Is your pharmacy prepared for its next BOP inspection? Let the Sweetgrass GxP team complete a gap assessment based on your state and applicable USP requirements and assist in developing an action plan to address any areas of concern.
Certainly, the best business practice is to always remain in a state of compliance, but sometimes an organization hits a bump in the road to full compliance, and Sweetgrass GxP is here to help. Whether you require assistance with remediation from a state BOP inspection, FDA Form 483, Warning Letter, Consent Decree or a DEA inspection, Sweetgrass GxP has the team and the knowledge to develop appropriate responses and action plans to return your pharmacy to compliance quickly, efficiently, and in a cost-effective manner.
The world of compounding is rapidly evolving, particularly regarding outsourcing facilities regulated by the FDA. Is your firm registered as a 503B? Do you have the Quality systems, processes, and procedures in place to meet the FDA Inspector's expectations? Do you have an experienced team that has been through dozens of FDA inspections? Sweetgrass GxP does, and is prepared to support your organization – today. Need to respond to an FDA Form 483? Let us help to develop a response that will assist you in closing the inspection and moving on to other challenges in your pharmacy operations.