Quality Assurance & Compliance

FDA Compliance Issue Resolution

We can assist you in preparing an effective response to an FDA Form 483 and Warning Letters. We can provide you with direction to ensure your quality system is in full compliance with the regulations. As part of our FDA Compliance Issue Resolution services, we will:

  • Analyze the findings of the FDA Form 483 and/or Warning Letter.
  • Suggest an appropriate timeline to satisfy the FDA.
  • Assist your company in charting a course of action.
  • Propose “Corrective Actions” to be made to your quality system.
  • Assist in implementing corrective actions in response to FDA Form 483.
  • Be available to answer all questions from you or the FDA during your efforts to correct the noted deficiencies or violations.
  • Compliance Audit. We can quickly help you with your compliance audit needs, including due diligence, vendor, GMP Gap, and Pre-Approval Inspection audits.

ATL has numerous Pharmaceutical, Medical Device and Consumer Product companies to formulate proper responses to FDA 483 and Warning Letters. Our team has the experience to resolve your issues by partnering with the FDA and putting you back on the right track

We work with our clients to ensure that the pharmaceutical and biotechnology products, as well as medical devices, meet a high level of quality is a full-scale endeavor. The processes, testing, and documentation behind those products must follow a consistent plan and meet current regulations. Each member of an organization, from executives to resource suppliers, plays a role in how quality is factored into a company’s operations, and ATL can help guide your company to making quality a repeatable and ongoing standard.