Quality System Remediation

"We can't solve problems by using the same kind of thinking we used when we created them" – Albert Einstein

Quality System Remediation

 

 

Receiving an unfavorable audit, or inspection report from internal auditors or external regulatory bodies can represent a major disruption to the business.

Our quality system remediation experts can help you determine the true root cause(s) of the findings and recommend a remediation approach that is tailored to your specific business needs. The natural tendency to remediation is to add layers of complexity, additional approvals or more prescriptive requirements to the quality system. Our experience has shown that this can have the opposite effect on your overall compliance efforts. Human nature is to follow the path of least resistance, this especially holds true in fast paced environments with tight delivery deadlines.

Our solutions will always explore the least prescriptive compliance approach to ensure that the least resistant approach is also the most compliant approach.

We provide quality system remediation assistance in the following areas:

Z

FDA Issue Remediation

– 483 and Warning Letter Responses
– Consent decree/injunction
– Submission deficiencies

Z

General Issues

– Complete quality system overhauls or focused actions
– Corrective action plans
– Recall management
– Audit management

Z

Notified Body Audits

– Major and minor findings response
– Competent authority notifications

Commons questions | QA

How long do we have to respond to an FDA 483?

Companies receiving an FDA Form 483, Inspectional Observations, have 15 working days to respond to the FDA. One way to avoid having your 483 turn into a warning letter is to make sure to include all necessary supporting documents within your response including revised documents, training records, and overall objective evidence of actions taken.

If we make changes to our corrective actions, should we notify the FDA or Notified Body?

Corrective actions taken as a result of an inspection or audit finding are almost always reviewed during subsequent visits, so any changes to the original corrective action plan should be communicated.

What if we have questions about an item listed in the report?

It is always best to get all questions answered before the inspector or auditor leaves your facility to make sure that everyone is clear about the noncompliance. If questions arise after the inspector or auditor has left, it is acceptable to contact them by email or phone, but be sure to be mindful of the response due date because it will not likely change due to questions.

Can someone outside of the company, such as a consultant or attorney, respond to observations on our behalf?

Yes they can, but be sure to attach a letter from the CEO and management representative indicating that they can communicate with the agency or notified body on your behalf.

Contact us today, to schedule a complimentary consultation.

CONNECT