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.

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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
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