FDA Compliance Consulting Services
FDA is concerned about the risk to patients from compounded drugs that do not meet the conditions in sections 503A or 503B. Gates Healthcare Associates, Inc. prepares its clients (either 503A compounding facilities, or 503B outsorucing facilities) to be FDA inspection ready, or support with any Form 483 response and remediation from previous inspections.
Request FDA Compliance Services
Detailed Services
Compliance with Section 503A
Mock FDA Inspection for 503A Compounding Pharmacies
Compliance with Section 503B
cGMP Compliance Assessments ⦿
Mock FDA Inspections (utilizing FDA's six system approach)
FDA Form 483 Response and Interpretation
Review and Interpret FDA Form 483 ⦿
Advise on appropriate response for Plan of Correction