QUALITY SYSTEM (Part 820 cGMP)
Implementation-Ready Quality System For Your Company
Quality System Audits
The outside audit puts new and objective eyes on your system. Since your Quality System is a living document and may undergo changes purposely or sometimes inadvertently. Subtle changes or more obvious ones may occur without recognition and documented change to your SOPs. From our experience, a good many of the 483s occur when the SOPS and the actual procedure do not match.
Our objective is to identify those non-conformances that may occur by omission or commission and assist your company in correcting any anomalies.
483 Observations & Warning Letter Responses
How serious is a 483 Observation?
It is serious since the inadequacy of your response can lead to further FDA actions including a Warning Letter. The object of careful response is to avoid that escalation of review.
I have received 483 Observations after my FDA inspection, how do I know if I am answering them correctly?
A company’s handling of responses to 483 Observations, Warning Letter and Recalls are critical to a company’s survival in the present FDA regulation climate. A company’s response must be timely, and comprehensive. Smith Associates has successfully assisted many companies in their responses to 483 observations to the FDA’s satisfaction.
Recalls and Corrections
A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective
Recalls may result from your 483 Observations or from a Warning Letter. Like all responses to the FDA, a Recall must be comprehensive and exhaustive in removing all recalled product from distribution. Smith Associates can provide the assistance to you company for:
Recall strategy
Health hazard evaluation
Coordination with FDA district office
Stock recovery – degree and depth of recall
Recall letter
Public warning
Recall status reports
Effectiveness checks